chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 20-year-old professional athletes that died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 20-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: DEATH (death, medically significant), outcome "fatal", described as "20-year-old professional athletes that died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: It (vaccine) was clearly not working. It was not safe and so many people were died from it. Stop allowing it under 30-year-old, and definitely under 18. There were 20-year-old professional athletes that died, it was crazy. It was not happened in 2020. People said the amount of deaths based in 2021 and 2022, not during the actual virus in 2020, it was crazy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: 20-year-old professional athletes that died
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Incorrect dose administered
Clinical narrative: Mild chills; Light headedness; The patient received 5th dose of Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: TYPHOID taken for immunisation, on 01Sep2022 as dose number unknown, single; TDAP taken for immunisation, on 31Aug2022 as dose number unknown, single; HEPATITIS A VACCINE;HEPATITIS B VACCINE taken for immunisation, on 01Sep2022 as dose number unknown, single; ELIQUIS; LAMOTRIGINE; CLONAZEPAM; QUETIAPINE. Past drug history included: On blood thinner (eliquis), notes: on blood thinner (Eliquis). Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Sep2022 at 11:00, outcome "unknown", described as "The patient received 5th dose of Comirnaty"; DIZZINESS (non-serious) with onset 08Sep2022 at 12:00, outcome "not recovered", described as "Light headedness"; CHILLS (non-serious) with onset 08Sep2022 at 12:00, outcome "not recovered", described as "Mild chills". Therapeutic measures were not taken as a result of chills, dizziness.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other vaccines within 4 weeks prior to the vaccination. The patient did not have any known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: woke up today with soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "woke up today with soreness at the injection site". Additional information: woke up today with soreness at the injection site.   The information on the batch/lot number for BNT162b2, BNT162b2 has been requested and will be submitted if and when received.;
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Also has soreness at the site; Also some mild body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose number unknown (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: Covid-19 vaccine (Primary series immunization completed, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "Also has soreness at the site"; PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "Also some mild body aches".  Additional information: My husband also had soreness at the site and also some mild body aches.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
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(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Aug2022 to 03Sep2022.  based on this Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 29Aug2022, Treatment stop date: 03Sep2022, Indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 03Apr2022 as dose 4 (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 was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative; (07Sep2022) Positive, notes: Rebound covid 19 infection/symptoms came back and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  Additional Information: No other medication in 2 weeks was received. No known allergies was reported. Anti viral details: Product-COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 28Aug2022,Treatment stop date: 02Sep2022 for the treatment of COVID-19. Rebound Covid 19 infection - after testing negative and symptoms resolved, symptoms came back and tested positive. Patient was Recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 years 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: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 01:30 PM as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 01:30 PM as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 at 09:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 03Jun2022 at 10:30 as dose 4 (booster), 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: "High Bood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Menieres Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol taken with codeine, reaction(s): "Allergies". 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: (unspecified date) Negative, notes: I had tested negative for 2 consecutive days; (unspecified date) Negative, notes: I had tested negative for 2 consecutive days; (unspecified date) Positive, notes: Treatment of COVID-19; (31Aug2022) Positive, notes: Tested positive again on the 8th day. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received Other medication in 2 weeks, which includes Celebrex, Chlorthalidone, Atorvastatin, Amlodipine, Losartan, Potassium, Vitamin D3, Vitamin B12 from unspecified dates of all medications in Aug2022 to Sep2022. It was reported that patient tested positive again on the 8th day after completing Paxlovid and had tested negative for 2 consecutive days prior to the positive test. Patient started Paxlovid as COVID 19 Treatment from 19Aug2022 to 23Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Jan2021 as dose 1, single (Lot number: 029L20A), in left arm and on 06Feb2022 as dose 2, single (Lot number: 029L20A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ARMOUR THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Positive rapid Ag test after 2 negative tests 48hrs apart; Negative, notes: Positive rapid Ag test after 2 negative tests 48hrs apart; Negative, notes: Positive rapid Ag test after 2 negative tests 48hrs apart. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 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: "Hidradenitis supprativa" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BACTRIM, start date: 23Aug2022, stop date: 01Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (08Sep2022) Positive, notes: Then day 5 afterward became congested again. Have been unable to get a negative test for 11 days now. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details:  product: COVID 19 Treatment: Brand: Paxlovid. Treatment start date: 30Aug2022 and Treatment stop date: 03Sep2022 Indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8727), in left arm, on 05May2021 as dose 2, single (Lot number: Er8727), in left arm and on 02Dec2021 at 10:00 as dose 3 (booster), 0.3ml single (Lot number: En0191) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing); "seasonal allergies" (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 "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (02Sep2022) Negative; (03Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient has no known allergies.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Known allergies: Seasonal allergies" (unspecified if ongoing); "Known allergies: cats" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: tested and I had two strongly positive tests; Positive, notes: tested and I had two strongly positive tests; Negative, notes: I tested negative 3 times on Friday; Negative, notes: I tested negative 3 times on Friday; Negative, notes: I tested negative 3 times on Friday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient took anti viral Paxlovid starting on 28Aug2022 and stopped on 02Sep2022 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.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound COVID; Rebound COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 08Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN; DILTIAZEM; SPIRONOLACTONE; FLUOXETINE; LANSOPRAZOLE; ROSUVASTATIN, stop date: 28Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (02Sep2022) Negative, notes: Rebound Covid. Tested negative on 02Sep2022; (07Sep2022) Positive, notes: Rebound symptoms started 06Sep2022. Tested positive for Covid on 07Sep2022 & 08Sep2022; (08Sep2022) Positive, notes: Rebound symptoms started 06Sep2022. Tested positive for Covid on 07Sep2022 & 08Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Prescribed Paxlovid to patient.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-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 was not reported. Patient had no known allergies. The patient took concomitant medications (within 2 weeks of vaccination). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product=COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started Paxlovid on 23Aug2022 for covid 19 treatment and stopped on 27Aug2022.   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 and a plausible temporal relationship, a possible causal association between the events Drug ineffective, Covid 19  and suspect drug BNT162B2 cannot be excluded.
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 10:30 as dose 3 (booster), single at the age of 67 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 and concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". 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: COVID 19 Treatment: Paxlovid, treatment start date: 07Sep2022 and stop date: Sep2022. Patient was taking Paxlovid 300mg Nirmatrelvir 100mg Ritonavir for covid 19.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound COVID after taking lower renal dose of Paxlovid; Rebound COVID after taking lower renal dose of Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 11:00 as dose number unknown, single (Lot number: FJ4989) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "stage 3 kidney disease" (unspecified if ongoing); "charcot marie tooth disease" (unspecified if ongoing); "lumbar stenosis" (unspecified if ongoing). Concomitant medication(s) included: DETROL LA; TAMSULOSIN; ALLOPURINOL; AMLODIPINE BESYLATE; RAMIPRIL; GABA [GABAPENTIN]. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound COVID after taking lower renal dose of Paxlovid". 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.  Clinical course: Anti-viral details: COVID 19 Treatment with Brand Paxlovid Lower renal dose, treatment started on 28Aug2022 till 01Sep2022, unknown lot number.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 21Mar2021 as dose 2, single (Lot number: GP7534), in left arm, on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart and vascular blockages with stents" (unspecified if ongoing), notes: Other medical history: Heart and vascular blockages with stents and a heart valve replacement; "Heart and vascular blockages with stents" (unspecified if ongoing), notes: Other medical history: Heart and vascular blockages with stents and a heart valve replacement; "a heart valve replacement" (unspecified if ongoing), notes: Other medical history: Heart and vascular blockages with stents and a heart valve replacement. Concomitant medication(s) included: XARELTO; CARVEDILOL; ATORVASTATIN; BABY ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (Sep2022) faint line, notes: Tested on Monday (Labor Day) and at first it looked clear but looking closer, there was a very, very faint line; (Sep2022) positive, notes: Decided to test and the positive line was quicker to show up and darker than any previous tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Sunday morning was last day of Paxlovid. Tested on Monday (Labor Day) and at first it looked clear but looking closer, there was a very, very faint line. No symptoms through Wednesday so I, thought I was clear. Thursday morning I started with a stuffy nose and thought it was allergies. Decided to test and the positive line was quicker to show up and darker than any previous tests. Putting our guard down, my wife was exposed more in the last couple of days. Symptoms are as bad or worse than the first, time around but got quick relief in a day the first time around.  Follow up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Body temperature, Illness, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: I have a friend who's 3 children were accidently given the adult COVID vaccine. The children have been pretty ill; I have a friend who's 3 children were accidently given the adult COVID vaccine. The children have been pretty ill; I have a friend who's 3 children were accidently given the adult COVID vaccine. The children have been pretty ill; one child still has low grade fever (2 weeks after vaccine).; This is a spontaneous report received from contactable reporter(s) from medical information team.  A child patient received BNT162b2 (COMIRNATY), in Aug2022 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: ILLNESS (non-serious) with onset 2022, outcome "unknown", ACCIDENTAL OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset Aug2022, outcome "unknown" and all described as "I have a friend who's 3 children were accidently given the adult COVID vaccine. The children have been pretty ill"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "one child still has low grade fever (2 weeks after vaccine).". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that 3 children were accidently given the adult COVID vaccine. The children have been pretty ill that week as a result. The reporter wanted to know if there might be some information available.  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-202201150492 similar report from same reporter;US-PFIZER INC-202201150493 similar report from same reporter;
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Illness, Product administered to patient of inappropriate age
Clinical narrative: 3 children were accidently given the adult COVID vaccine; 3 children were accidently given the adult COVID vaccine; The children have been pretty ill this week; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A patient received BNT162b2 (COMIRNATY), 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: ACCIDENTAL OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown" and all described as "3 kids were accidently given the adult COVID vaccine"; ILLNESS (non-serious), outcome "unknown", described as "The kids have been pretty ill this week".  Additional information: It was reported that 3 kids were accidently given the adult COVID vaccine. The kids have been pretty ill that week as a result. The reporter wanted to know if there might be some information available.  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-202201150442 Same reporter/product/dose/different patients;
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Illness, Product administered to patient of inappropriate age
Clinical narrative: I have a physician friend who's 3 children were accidently given the adult COVID vaccine. The children have been pretty ill; I have a physician friend who's 3 children were accidently given the adult COVID vaccine. The children have been pretty ill; I have a physician friend who's 3 children were accidently given the adult COVID vaccine. The children have been pretty ill; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A child patient received BNT162b2 (COMIRNATY), in Aug2022 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: ILLNESS (non-serious) with onset 2022, outcome "unknown", PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset Aug2022, outcome "unknown" and all described as "I have a physician friend who's 3 children were accidently given the adult COVID vaccine. The children have been pretty ill".  Additional information: It was reported that 3 children were accidently given the adult COVID vaccine. The children were ill on the vaccinated week.  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-202201150442 similar report from same reporter;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Ocular hyperaemia, Periorbital swelling, Swelling face
Clinical narrative: flare-ups where my eyes get completely puffy; underneath my eyes there's splotches of red patches; flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I'm allergic to Penicillin" (unspecified if ongoing), notes: She added "I'm allergic to Penicillin, So I'm not sure if the vaccines have penicillin in them?. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Underneath my eyes there's splotches of red patches", "Flare-ups where my eyes get completely puffy", "Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Underneath my eyes there's splotches of red patches", "Flare-ups where my eyes get completely puffy". The following information was reported: PERIORBITAL SWELLING (non-serious), outcome "unknown", described as "flare-ups where my eyes get completely puffy"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "underneath my eyes there's splotches of red patches"; SWELLING FACE (non-serious), outcome "unknown", described as "flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks". Relevant laboratory tests and procedures are available in the appropriate section  Additional information: The patient had received 3 Pfizer shots the last one was in December, from past month and half the patient was suffering from weird allergic reactions around her face.  Reported NTID number.  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: Condition aggravated, Ocular hyperaemia, Periorbital swelling, Swelling face
Clinical narrative: flare-ups where my eyes get completely puffy; underneath my eyes there's splotches of red patches; flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I'm allergic to Penicillin" (unspecified if ongoing), notes: She added "I'm allergic to Penicillin, So I'm not sure if the vaccines have penicillin in them?. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Underneath my eyes there's splotches of red patches", "Flare-ups where my eyes get completely puffy", "Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Underneath my eyes there's splotches of red patches", "Flare-ups where my eyes get completely puffy". The following information was reported: PERIORBITAL SWELLING (non-serious), outcome "unknown", described as "flare-ups where my eyes get completely puffy"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "underneath my eyes there's splotches of red patches"; SWELLING FACE (non-serious), outcome "unknown", described as "flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks". Relevant laboratory tests and procedures are available in the appropriate section  Additional information: The patient had received 3 Pfizer shots the last one was in December, from past month and half the patient was suffering from weird allergic reactions around her face.  Reported NTID number.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with Covid after vaccination; Diagnosed with Covid after vaccination; 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 male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) 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: "COPD" (unspecified if ongoing), notes: Both have COPD and emphysema.; "emphysema" (unspecified if ongoing), notes: Both have COPD and emphysema. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Diagnosed with Covid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller stated that his wife and himself they both had COVID back on May. He took Paxlovid and she took a monoclonal antibodies therapy. Caller wanted to know if they were still eligible for the new bivalent booster dose of the Pfizer-BioNTech COVID-19 Vaccine. He mentioned that he had the 2 primary series and 1 booster dose from Pfizer (and he had COVID on May). He didn't specified this for his wife.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Periorbital swelling, Swelling face
Clinical narrative: Flare-ups where my eyes get completely puffy; Underneath my eyes there's splotches of red patches; Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks; 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 48-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I'm allergic to Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIORBITAL SWELLING (non-serious), outcome "unknown", described as "Flare-ups where my eyes get completely puffy"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "Underneath my eyes there's splotches of red patches"; SWELLING FACE (non-serious), outcome "unknown", described as "Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks".  Additional Information: The patient received 3 shots of the covid -19 vaccine and wanted to know the side effects because she had swelling. The patient received last Pfizer shot in Dec2021, and the past couple of months had been just getting these off and on what patient thought were allergic reactions. But they are flare-ups where eyes get completely puffy, and even underneath eyes there are splotches of red patches, so seemingly looks like an allergic reactions. The patient work on the computer all day, so not being able to see because of these puffy eyes was not good. The patient noted, got allergy tested, literally not allergic to anything. The patient had a rheumatologist check out for lupus, that's not the answer. The patient was looking for more information about possible recurring side effects, adding everything look up on the internet says the risk of not getting the vaccine outweighs the risk of getting it. No information regarding recurrence of adverse events over a period of months after administration. Caller was a consumer who reported a recurring reactions to the Pfizer Covid19 vaccine. It was reported that patient received two of boosters. The patient experienced just somewhat flare up where entire face just completely swelled up. The patient just wondering if anyone had reported any such side effects or allergic reactions post vaccine because there was no rhyme or reason to why the patient getting these flare ups and there new.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia, Periorbital swelling, Swelling face
Clinical narrative: flare-ups where my eyes get completely puffy; underneath my eyes there's splotches of red patches; Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks; Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks; 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 48-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 included: "I'm allergic to Penicillin" (unspecified if ongoing), notes: I'm allergic to Penicillin, So I'm not sure if the vaccines have penicillin in them. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization.  The following information was reported: PERIORBITAL SWELLING (non-serious), outcome "unknown", described as "flare-ups where my eyes get completely puffy"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "underneath my eyes there's splotches of red patches"; SWELLING FACE (non-serious), EYE SWELLING (non-serious), outcome "unknown" and all described as "Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 25May2022 at 20:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sinuses" (unspecified if ongoing), notes: Sinuses was taking cholesterol pills but stopped temporarily to be treatment. 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 Treatment". 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.  Clinical course: The patient received Paxlovid for treatment of Covid-19 from 31Aug2022 to 06Sep2022. No adverse effect, mild systems but 5 days after Paxlovid tested positive with sore throat similar to strep throat. No known allergies. 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6206), in right arm, on 24Mar2021 as dose 2, single (Lot number: ER8730), in right arm, on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 27May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "PMLE" (unspecified if ongoing), notes: Other medical history: PMLE; "BRCA2 positive" (unspecified if ongoing), notes: Other medical history: BRCA2 positive. Concomitant medication(s) included: SAXENDA, start date: 09Aug2021; PREDNISONE, start date: 05Sep2022, stop date: 05Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient had loose stools are very light, champagne-colored - called doctor and she said to stop taking the medication and if my stools remain light over the weekend to get a liver panel done. Patient had no known allergies. It was reported that patient received vaccine. Patient received other medication in 2 weeks. Patient received Paxlovid treatment for COVID 19.