chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got a positive covid infection.; Got a positive covid infection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 24Mar2021 as dose 2, single (Lot number: EL3248), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: FH80207) at the age of 42 years, in left arm for covid-19 immunisation at Workplace clinic. The patient's relevant medical history and concomitant medications were not reported. Patient had no covid prior to vaccination. It was reported that patient didn't took other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jun2022, outcome "recovered" (Jun2022), COVID-19 (medically significant) with onset 18Jun2022, outcome "recovered" (Jun2022) and all described as "Got a positive covid infection.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive. Patient tested for covid post vaccination. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EL3247), on 21Mar2021 as dose 2, single (Lot number: EL3247) and on 22Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown, notes: if covid prior vaccination; (14Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.  ; Sender's Comments: The reported Covid 19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 34-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3247), on 15Feb2021 as dose 2, single (Lot number: EL3247) and on 18Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: asymptomatic covid; asymptomatic covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431030-00. A 50-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular 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; adalimumab (HUMIRA), from 03Dec2021 (Batch/Lot number: unknown) to 2022 at 40 mg (40 mg, 1 in 2 wk), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "asymptomatic covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive. The action taken for adalimumab was unknown. Clinical course: Asymptomatic covid with humira (adalimumab).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 09:15 as dose 4 (booster), single (Lot number: FM0698) at the age of 82 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "tachy/brady syndrome" (unspecified if ongoing); "tachy/brady syndrome" (unspecified if ongoing); "chronic hypothyroidism" (unspecified if ongoing); "mild hypertension" (ongoing); "Known allergies: sulfonamides" (unspecified if ongoing); "Known allergies: scallops" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was treated with Paxlovid from 13Jun2022 to 17Jun2022. The patient did not received any other medication in 2 weeks.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Gingival bleeding, Investigation, Ulcer
Clinical narrative: every time she gets a dose of vaccine she gets mouth blisters and ulcers and bleeding gums and this happens every time within 7 days of the dose of vaccine; every time she gets a dose of vaccine she gets mouth blisters and ulcers and bleeding gums and this happens every time within 7 days of the dose of vaccine; every time she gets a dose of vaccine she gets mouth blisters and ulcers and bleeding gums and this happens every time within 7 days of the dose of vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female 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, she had three booster doses of the Pfizer BioNTech covid-19 vaccine , Caller stated that every time she gets a dose of vaccine she gets mouth blisters and ulcers and bleeding gums and this happens every time within 7 days of the dose of vaccine;), for COVID-19 immunization, reaction(s): "she gets mouth blisters", "bleeding gums"; Bnt162b2 (DOSE: 1, she had three booster doses of the Pfizer BioNTech covid-19 vaccine , Caller stated that every time she gets a dose of vaccine she gets mouth blisters and ulcers and bleeding gums and this happens every time within 7 days of the dose of vaccine;), for Covid-19 immunization, reaction(s): "ulcers". The following information was reported: BLISTER (non-serious), ULCER (non-serious), GINGIVAL BLEEDING (non-serious), outcome "unknown" and all described as "every time she gets a dose of vaccine she gets mouth blisters and ulcers and bleeding gums and this happens every time within 7 days of the dose of vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 on 27Jun2022. Symptoms included headache, sore throat, and coughing and nasal congestion that began 24Jun2022.; Tested positive for COVID-19 on 27Jun2022. Symptoms included headache, sore throat, and coughing and nasal congestion that began 24Jun2022.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in left arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FF7588), in left arm and on 01Jun2022 as dose 4 (booster), single (Lot number: F54991) at the age of 62 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jun2022, outcome "not recovered" and all described as "Tested positive for COVID-19 on 27Jun2022. Symptoms included headache, sore throat, and coughing and nasal congestion that began 24Jun2022.". The events "tested positive for covid-19 on 27jun2022. symptoms included headache, sore throat, and coughing and nasal congestion that began 24jun2022." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive; (24Jun2022) Negative, notes: COVID test type post vaccination: Nasal Swab; (26Jun2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included no other vaccines within 4 weeks prior to the COVID vaccine. Amoxicillin, Mucinex, Tylenol, and Excedrin to treat symptoms; stopped after tested positive. patient was not diagnosed with COVID-19 prior to vaccination. Awareness Date: 26Jun2022. The case was reported as non serious. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: Treatment of COVID-19; (26Jun2022) positive, notes: I still test positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 17Jun2022 to 21Jun2022 for treatment of COVID-19. The patient did not received other medication in 2weeks. It was reported that 5 days after completing Paxlovid course respiratory symptoms have recurred and I still test positive for Covid. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure (treated)" (unspecified if ongoing), notes: other medical history: High blood pressure (treated); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (Jun2022) Negative, notes: tested negative over 3 days; (Jun2022) Positive, notes: tested positive with a resumption of Covid symptoms. 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: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Test positive for covid; Test positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2022 at 15:00 as dose number unknown (booster), single (Lot number: FK9893), in right arm, on 11Mar2021 at 15:00 as dose number unknown, single (Lot number: EN6208), in left arm, on 22Feb2021 at 15:00 as dose number unknown , single (Lot number: En6200), in left arm, (Batch/Lot number: unknown) and (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Aug2021 at 15:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa drugs" (unspecified if ongoing); "Polymyositis recurrent" (unspecified if ongoing). Concomitant medication(s) included: AZATHIOPRINE taken for immunosuppressant drug therapy, start date: 31Dec2021, stop date: 12Jun2022. Past drug history included: Gluten, reaction(s): "known allergies: Gluten". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Test 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. Clinical course: The patient took other medication in 2weeks. Increasing sinusitis by day 5 after completing the 5 day Paxlovid. Test positive for covid with a Binax otc kit. Was 5 day paxlovid enough. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 50 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. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin.  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: Rebound COVID - symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood magnesium, Pruritus
Clinical narrative: it itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2021 as dose 1, single (Lot number: EWD171) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: Cholesterol; "gastrointestinal problem" (unspecified if ongoing), notes: I have a gastrointestinal problem; "kidney problem" (unspecified if ongoing), notes: I was having a kidney problem; "kidney stone", start date: 2000 (unspecified if ongoing), notes: I passed a kidney stone and that was way back in early 2000. Concomitant medication(s) included: LOVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Hepatitis b vaccine. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "it itches". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 71.0
Sex: M
Vaccine: 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) (Other HCP).  A 71-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 at 15:45 as dose 3 (booster), single (Lot number: PFZER33030BD) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Apr2021 at 13:15 as dose 1, single (Lot number: 040B21A), in right arm and on 23May2021 at 14:30 as dose 2, single (Lot number: 025C21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, start date: 22Jun2022, stop date: 27Jun2022; ROPINIROLE, start date: 22Jun2022, stop date: 27Jun2022; AMLODIPINE, start date: 22Jun2022, stop date: 27Jun2022; ATORVASTATIN, start date: 22Jun2022, stop date: 27Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED 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: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive covid test; positive covid test; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2022 as dose 4 (booster), single (Lot number: FJ1614) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Lot number: 032L20A), on 22Feb2021 as dose 2, single (Lot number: 022M20A) and on 13Aug2021 as dose 3 (booster), single (Lot number: 026D21A) for covid-19 immunisation. The patient's relevant medical history included: "systemic sarcoidosis" (unspecified if ongoing); "cardiomyopathy" (unspecified if ongoing). Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL], start date: Jun2018, stop date: 15Jun2022; HUMIRA, start date: Jul2019, stop date: 15Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jun2022, outcome "not recovered" and all described as "positive covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jun2022) Positive, notes: positive at home COVID test 7 days after COMPLETING 5 day course of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech, product=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 55-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 at 16:45 as dose number unknown, single (Lot number: FM9992), in right 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) all with onset 16Jun2022, outcome "recovering" and all described as "vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (16Jun2022) 100.5, notes: Fever; SARS-CoV-2 test: (15Jun2022) negative, notes: Returned afternoon of 6/15, tested negative at 3pm; (16Jun2022) Strong positive, notes: Strong positive Thursday the 16th at 7am; (21Jun2022) positive, notes: took at-home test the 21st afternoon. Very faint line of positive; (23Jun2022) positive, notes: Thursday 23rd took PCR/antigen test locally, tested positive; (25Jun2022) positive, notes: Tested VERY strong line positive Saturday morning 10am (fever). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional reporter: Paxlovid Rebound. Attended a Business Trip 13Jun2022- 15Jun2022. No one was wearing masks in planes/airport/casinos/restaurants. Patient wore an N95 mask 75% of the time (except at customer dinners and mixers). Returned afternoon of 15Jun2022, tested negative at 3pm - Symptoms Wed Evening (phlegm, congestion, slight fever, headache, fatigue, body aches). Strong positive Thursday the 16Jun2022 at 7am. Fever 100.5. Took first dose of Paxlovid Thursday the 16Jun2022 at 6pm. Last Dose Paxlovid Tuesday the 21Jun2022 at 8am. Started improving, took at-home test the 21Jun2022 afternoon. Very faint line of positive. Continued improvement with some symptoms (congestion, cough). Thursday 23Jun2022 took PCR/antigen test locally, tested positive. Friday throughout the night symptoms increased. Saturday am 25Jun2022, woke up with body aches, congestion, headache, fatigue/brain fog. NO fever. Felt like the original symptoms. Tested very strong line positive Saturday morning 10am (fever). Still sick Monday 27Jun2022.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies : Penicillin" (unspecified if ongoing). Patient didn't took other medication in 2 weeks. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Nov2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold induced asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received treatment from 14Jun2022 to 18Jun2022 for COVID 19 Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
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) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: MOTRIN [IBUPROFEN], start date: 31May2022, stop date: 26Jun2022.  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: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: 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 49-year-old female patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3,(booster) single (Batch/Lot number: unknown) at the age of 49 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 was not reported. There were no concomitant medications.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient was treated with anti-viral product (Paxlovid) from 18Jun2022 to 22Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Dose 1: 29Jan2021; Dose 2: 07Feb2021; she forgot to take the several medicines; stomach problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 2, single (Lot number: EN6201) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "She takes her blood pressure" (unspecified if ongoing), notes: She takes her blood pressure; "She was on a few medications over the 10 years for pain" (unspecified if ongoing), notes: She was on a few medications over the 10 years for pain.; "Pain in her nerves, muscles, and tendons" (unspecified if ongoing), notes: Pain in her nerves, muscles, and tendons.; "She did start with the pain in her foot" (unspecified if ongoing), notes: She did start with the pain in her foot. Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal; NUCYNTA taken for pain; SAVELLA taken for pain; ORPHENADRINE taken for pain; AMITRIPTYLINE taken for pain; TYLENOL taken for pain; CODEINE taken for pain; HYDROCHLOROTHIAZIDE. Past drug history included: Levaquin, reaction(s): "nerve pain, muscle and joint pain", notes: I had a reaction to Levaquin 11 years ago and had nerve pain , muscle and joint pain that was horrible at times; Levaquin, reaction(s): "nerve pain, muscle and joint pain", notes: I had a reaction to Levaquin 11 years ago and had nerve pain , muscle and joint pain that was horrible at times; Levaquin, reaction(s): "nerve pain, muscle and joint pain", notes: I had a reaction to Levaquin 11 years ago and had nerve pain , muscle and joint pain that was horrible at times; Levaquin, reaction(s): "nerve pain, muscle and joint pain", notes: I had a reaction to Levaquin 11 years ago and had nerve pain , muscle and joint pain that was horrible at times. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN5318, 72115121), administration date: 29Jan2021, when the patient was 77-year-old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose 1: 29Jan2021; Dose 2: 07Feb2021"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "she forgot to take the several medicines"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "stomach problems".  Additional information: It was reported that 11 years ago she had a reaction due to Levaquin that affected her nervous system, her joints and muscles. So she started to take Nucynta, Savella, Ephedrine and Amitriptyline in order to control her pain for almost 10 years. She received her second shot and she realized she forgot to take all her medicines for her pain but she was having no pain at all and sudden she felt well. Now she has been a year without pain. It was also reported that patient was not having other conditions and did not underwent investigation.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: had the same tingly arm sensations but they were more mild but not as bad as the second shot; 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 female patient 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 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "felt something itchy on the left underside of her arm/ itching/ had the same feeling on the right side from armpit to wrist". The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "had the same tingly arm sensations but they were more mild but not as bad as the second shot".  Additional information: She has a lot of allergies, she used to get allergy shots a long time ago. With the two boosters from Pfizer, she had the same tingly arm sensations but they were more mild but not as bad as the second shot. She became more accustomed to it and knew how to deal with it.  She doesn't remember if vaccine was given on left or right side. While waiting after the injection she was fine but after she got in car, she felt weird little mosquito bite, and then started to grow. Sensation never went away 100% but subsided and got tolerable. When she got Covid, all of a sudden it came back, a twingy feeling under both arms. She takes no medications and is very healthy.  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: Paraesthesia
Clinical narrative: had the same tingly arm sensations but they were more mild but not as bad as the second shot; 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 71-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to wool" (unspecified if ongoing), notes: she's allergic to wool; "She has a lot of allergies" (unspecified if ongoing), notes: She has a lot of allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): "she was fine"; Bnt162b2 (Dose 2, single), for Covid-19 immunization, reaction(s): "she felt something itchy on the left underside of her arm"; Bnt162b2 (Dose 3 (Booster), single), for Covid-19 immunization, reaction(s): "she had the same tingly arm sensations". The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "had the same tingly arm sensations but they were more mild but not as bad as the second shot".  Additional information: patient did have some side effects after the Pfizer BioNTech Covid 19 vaccines, she received the first two initial doses as well as both boosters, and all shots were Pfizer. When she got the first vaccination she was fine. After the second vaccination, within 15 minutes or so she felt something itchy on the left underside of her arm. It was about a year and half ago in the winter and she was wearing a wool sweater and she's allergic to wool. She changed to a cotton sweater but the itching continued. It was a weird sensation from armpit to wrist on the underside. Its an unusual sensation, it feels like something under the skin like heebee geebees, creepy crawly sensations, like a mosquito bite but keeps spreading. Within two weeks she had the same feeling on the right side from armpit to wrist. Its always been there but now its subsided. Now with Covid, it has reactivated and flared up again a little bit, now can deal with it. She has a lot of allergies, she used to get allergy shots a long time ago. With the two boosters from Pfizer, she had the same tingly arm sensations but they were more mild but not as bad as the second shot. She became more accustomed to it and knew how to deal with it. She doesn't remember if vaccine was given on left or right side. While waiting after the injection she was fine but after she got in car, she felt weird little mosquito bite, and then started to grow. Sensation never went away 100% but subsided and got tolerable. When she got Covid, all of a sudden it came back, a twingy feeling under both arms. She takes no medications and is very healthy.  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, Suspected COVID-19
Clinical narrative: had the same tingly arm sensations but they were more mild but not as bad as the second shot; 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 71-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to wool" (unspecified if ongoing), notes: she's allergic to wool; "She has a lot of allergies" (unspecified if ongoing), notes: She has a lot of allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): "she was fine"; Bnt162b2 (Dose 2, single), for Covid-19 immunization, reaction(s): "she felt something itchy on the left underside of her arm"; Bnt162b2 (Dose 3 (Booster), single), for Covid-19 immunization, reaction(s): "she had the same tingly arm sensations". The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "had the same tingly arm sensations but they were more mild but not as bad as the second shot".  Additional information: patient did have some side effects after the Pfizer BioNTech Covid 19 vaccines, she received the first two initial doses as well as both boosters, and all shots were Pfizer. When she got the first vaccination she was fine. After the second vaccination, within 15 minutes or so she felt something itchy on the left underside of her arm. It was about a year and half ago in the winter and she was wearing a wool sweater and she's allergic to wool. She changed to a cotton sweater but the itching continued. It was a weird sensation from armpit to wrist on the underside. Its an unusual sensation, it feels like something under the skin like heebee geebees, creepy crawly sensations, like a mosquito bite but keeps spreading. Within two weeks she had the same feeling on the right side from armpit to wrist. Its always been there but now its subsided. Now with Covid, it has reactivated and flared up again a little bit, now can deal with it. She has a lot of allergies, she used to get allergy shots a long time ago. With the two boosters from Pfizer, she had the same tingly arm sensations but they were more mild but not as bad as the second shot. She became more accustomed to it and knew how to deal with it. She doesn't remember if vaccine was given on left or right side. While waiting after the injection she was fine but after she got in car, she felt weird little mosquito bite, and then started to grow. Sensation never went away 100% but subsided and got tolerable. When she got Covid, all of a sudden it came back, a twingy feeling under both arms. She takes no medications and is very healthy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: 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 28-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Additional information: Antiviral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=22Jun2022, Treatment stop date=26Jun2022, Lot number=GA3581 and Indication=Treatment of COVID-19. Patient not received other medication in 2weeks. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccine brand: Pfizer/BioNTech, product: COVID 19 Treatment; Vaccine brand: Pfizer/BioNTech, product: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL8982), on 09Feb2021 as dose 2, single (Lot number: EN5318) and on 13Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Lot number: 027L21A) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. Concomitant medication(s) included: TRAZODONE; LISINOPRIL; CETIRIZINE HYDROCHLORIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Vaccine brand: Pfizer/BioNTech, product: 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 vaccination failure, covid-19.  Clinical course: Other medication in 2weeks: Multivitamin, Omega 3 (brand- Spring Valley). Antiviral details- Product: COVID 19 Treatment, Brand: Paxlovid (Treatment start date: 15Jun2022, Treatment stop date:19Jun2022). After about four and a half days of no symptoms, congestion and cough returned on 16Jun2022. Patient had no known allergies.; Sender's Comments: Based on the available reported information, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment; Positive, notes: Tested positive again with milder symptoms 3 days after finishing paxlovid. Therapeutic measures were taken as a result of drug ineffective, 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: Drug ineffective, 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.