chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID 19; Treatment of COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 20Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: EW0186-H) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 11Jul2022, outcome "not recovered" and all described as "Treatment of COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive line was dark; (20Jul2022) Positive line is still shown, notes: and still showed a dark line before reaching the control line; (11Jul2022) Positive; (17Jul2022) Faint positive line. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information includes the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. The patient was tested positive on 11Jul2022 using a home antigen test and started taking Paxlovid on 11Jul2022 through the 5 days and symptoms quickly resolved, feeling better just 2 days later. The patient started feeling symptoms again on 19Jul2022 and antigen test on Sunday morning, 17Jul2022 showed a faint positive line. Beginning on Monday, 18Jul2022, the positive line was dark and showed positive before reaching the control line on the test. On Wednesday, 20Jul2022, the positive line is still shown and still showed a dark line before reaching the control line. The Adverse event start date for Paxlovid was on 19Jul2022 which resulted in none of the serious criteria and not recovered yet. The patient did not receive any treatment for the event with Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Gait disturbance, Loss of personal independence in daily activities, Nausea
Clinical narrative: Vertigo that resulted in minor car accident; Vertigo that resulted in minor car accident; Dizziness and nausea lasting for 2 days; Dizziness and nausea lasting for 2 days; Interfered with standing, walking, and completing daily tasks; Interfered with standing, walking, and completing daily tasks; Interfered with standing, walking, and completing daily tasks; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 87-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 87 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing); "Heart failure" (unspecified if ongoing); "Ventricular arrhythmia" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: known allergies: penicillin (distant history of rash/hives). Concomitant medication(s) included: METFORMIN; GLIMEPIRIDE; FUROSEMIDE; AMIODARONE; CARVEDILOL; LISINOPRIL. Past drug history included: Codeine, reaction(s): "Drug hypersensitivity", notes: known allergies:Codeine. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 15Jul2022, outcome "recovered" (17Jul2022) and all described as "Dizziness and nausea lasting for 2 days"; DYSSTASIA (non-serious), GAIT DISTURBANCE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 15Jul2022, outcome "recovering" and all described as "Interfered with standing, walking, and completing daily tasks"; VERTIGO (non-serious), ROAD TRAFFIC ACCIDENT (non-serious) all with onset 15Jul2022, outcome "recovering" and all described as "Vertigo that resulted in minor car accident". Therapeutic measures were not taken as a result of vertigo, road traffic accident, dizziness, nausea, dysstasia, gait disturbance, loss of personal independence in daily activities.  Additional information: It was reported that patient received more than 3 dose of COVID-19 Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Road traffic accident, Vertigo
Clinical narrative: Vertigo that resulted in minor car accident; Vertigo that resulted in minor car accident; Dizziness and nausea lasting for 2 days; Dizziness and nausea lasting for 2 days; Interfered with standing, walking, and completing daily tasks; Interfered with standing, walking, and completing daily tasks; Interfered with standing, walking, and completing daily tasks; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 87-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 87 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing); "Heart failure" (unspecified if ongoing); "Ventricular arrhythmia" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: known allergies: penicillin (distant history of rash/hives). Concomitant medication(s) included: METFORMIN; GLIMEPIRIDE; FUROSEMIDE; AMIODARONE; CARVEDILOL; LISINOPRIL. Past drug history included: Codeine, reaction(s): "Drug hypersensitivity", notes: known allergies:Codeine. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 15Jul2022, outcome "recovered" (17Jul2022) and all described as "Dizziness and nausea lasting for 2 days"; DYSSTASIA (non-serious), GAIT DISTURBANCE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 15Jul2022, outcome "recovering" and all described as "Interfered with standing, walking, and completing daily tasks"; VERTIGO (non-serious), ROAD TRAFFIC ACCIDENT (non-serious) all with onset 15Jul2022, outcome "recovering" and all described as "Vertigo that resulted in minor car accident". Therapeutic measures were not taken as a result of vertigo, road traffic accident, dizziness, nausea, dysstasia, gait disturbance, loss of personal independence in daily activities.  Additional information: It was reported that patient received more than 3 dose of COVID-19 Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiomegaly, Myocardial infarction, Swelling
Clinical narrative: have got constant heart attack for like 6 months; I proceed to have a heart attack all that time; swollen heart; my body was swollen, my veins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "have got constant heart attack for like 6 months; I proceed to have a heart attack all that time"; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "my body was swollen, my veins"; CARDIOMEGALY (non-serious) with onset 2021, outcome "unknown", described as "swollen heart". Clinical course: Concern: Consumer stated, Patient just called to let know what Pfizer did to patient to just vent, to make patient feel better. patient have got constant heart attack for like 6 months (Further clarification unknown, hence event captured as per verbatim) and in Apr2021. Patient got first shot and on May 6th patient got second shot (further clarification unknown, hence captured as unspecified shot), patient proceed to have a heart attack all that time. Patient didn't know so patient went to cardiologist in December, no October. It has some time of gap between the time patient saw last and this time, it took long time to find out that patient was a heart attack everything patients body was swollen, veins, heart (Further clarification unknown, hence event captured as per verbatim), somebody problems, patient though this was over and after coming out of it where have been feeling, it should have ended. Thank you Pfizer. Further probing could not be done as consumer abruptly hung up the call. Hence, product details (LOT#, NDC#, UPC# and expiration) were unknown and limited information available over the call. QR Comment: Reporter type could not be clarified over the call. Hence, captured as consumer or other non health care professional conservatively.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 74-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 25Feb2021 as dose 2, single (Lot number: EL9265), in left arm and on 31Aug2021 as dose 3 (booster), single (Lot number: ew0187) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Lot number: 002m21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 15:00 as dose 1, single (Lot number: EL9267), in right arm and on 03Mar2021 at 13:00 as dose 2, single (Lot number: EN6204) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bleeding peptic ulcer" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing); "C-Diff" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "known allergies: Ceclor"; Nsaids, reaction(s): "known allergies: NSAIDS". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Anti-viral details treatment start date was on 14Jul2022, treatment stop date was on 15Jul2022, Lot number= 2815213 for indication of treatment of COVID-19.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 15:00 as dose 1, single (Lot number: EL9267), in right arm and on 03Mar2021 at 13:00 as dose 2, single (Lot number: EN6204) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bleeding peptic ulcer" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing); "C-Diff" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "known allergies: Ceclor"; Nsaids, reaction(s): "known allergies: NSAIDS". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Anti-viral details treatment start date was on 14Jul2022, treatment stop date was on 15Jul2022, Lot number= 2815213 for indication of treatment of COVID-19.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: extreme tiredness - couldn't stay away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 13:00 as dose 2, single (Lot number: EN6204) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bleeding peptic ulcer" (unspecified if ongoing); "lactose intolerant" (unspecified if ongoing); "had C-Diff" (unspecified if ongoing); "Known allergies: nsaids" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: ceclor, reaction(s): "Known allergies: Ceclor". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL9267, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 10Feb2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "extreme tiredness - couldn't stay away".  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness - couldn't stay away". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Past drug included NSAIDs.   No follow-up attempts are possible; No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: extreme tiredness - couldn't stay away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 13:00 as dose 2, single (Lot number: EN6204) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bleeding peptic ulcer" (unspecified if ongoing); "lactose intolerant" (unspecified if ongoing); "had C-Diff" (unspecified if ongoing); "Known allergies: nsaids" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: ceclor, reaction(s): "Known allergies: Ceclor". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL9267, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 10Feb2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "extreme tiredness - couldn't stay away".  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness - couldn't stay away". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Past drug included NSAIDs.   No follow-up attempts are possible; No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: extreme tiredness - couldn't stay away; extreme tiredness - couldn't stay away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 15:00 as dose 1, single (Lot number: EL9267) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Bleeding peptic ulcer" (unspecified if ongoing); "lactose intolerant" (unspecified if ongoing); "C-Diff" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: FATIGUE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown" and all described as "extreme tiredness - couldn't stay away". Therapeutic measures were taken as a result of fatigue, loss of personal independence in daily activities. Additional information: No Other medication in 2weeks.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Heart rate, 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 75-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure controlled" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Heart rate: (20Jul2022) Low pulse, notes: Low pulse, varies from 39 to 59. Mostly between 43-57; SARS-CoV-2 test: (unspecified date) Unknown results, notes: indication: Treatment of COVID-19. 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Vomiting
Clinical narrative: violently sick throwing up/vomiting; I was vomiting and chills; violently sick throwing up/vomiting; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 19Jul2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "coronary artery disease" (unspecified if ongoing), notes: I have coronary artery disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "vomiting"; Bnt162b2 (Dose 3 Booster, I was vomiting and chills), for Covid-19 immunization, reaction(s): "chills", "vomiting". The following information was reported: VOMITING (non-serious) with onset 19Jul2022 at 23:00, outcome "unknown", ILLNESS (non-serious), outcome "unknown" and all described as "violently sick throwing up/vomiting"; CHILLS (non-serious), outcome "unknown", described as "I was vomiting and chills". Additional information: the reporter stated she was violently sick throwing up. She was up all night and vomiting with the vaccine, every time I take it, this is what happens. The reporter stated the first time she didn't vomit, the second dose she was vomiting up a storm, the first and second booster she was vomiting and chills.  The reporter just received the last booster yesterday, she was okay in the beginning and started vomiting about. She received the vaccine at 1:30pm and started vomiting at 11PM and it lasted all night until about 8 or 9AM , she was up every hour on the hour vomiting.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia, SARS-CoV-2 test
Clinical narrative: 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 67-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, (SINGLE), she has taken three Pfizer Covid 19 Vaccines), for COVID-19 immunization; Bnt162b2 (DOSE 2, (SINGLE), she has taken three Pfizer Covid 19 Vaccines), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Caller voiced she had five days of fever. She didn't believe the fog was real that everyone talks about but, it is"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "fog". Relevant laboratory tests and procedures are available in the appropriate section. Additional information included that the patient took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid. Caller voiced "She had no immunity from the shots didn't work or now it's been to long spaced out. Was what she was thinking. Does that sound like what's happened or could had just got one that the shots don't work? Caller voiced that she had taken three Pfizer Covid 19 Vaccines since covid started. Per caller she thinks the last one was probably the very end of Oct. Caller asking now that she has covid and has taken the three Pfizer Covid Vaccines and will possibly take the Paxlovid once consulting with HCP will she have enough immunity to put off the second Pfizer Covid 19 booster until later? Caller voiced she had five days of fever. She didn't believe the fog was real that everyone talks about but, it is. It"seems like everything she was reading it's talking about people clotting that had covid. They found clots in people after they died when doing autopsy's and stuff." The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Erythema, Rash
Clinical narrative: redness in arm; rashes is still there almost after a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15Jul2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "redness in arm"; RASH (non-serious), outcome "not recovered", described as "rashes is still there almost after a week". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 63-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Report about covid treatment: Yes. if vaccine received: Yes. Patient did not received other medication in 2weeks. Patient received treatment with paxlovid start date: 09Jul2022 and stop date: 06Jul2022. Indication.Adverse event : Covid rebound Day 11. Adverse event country :  Adverse event start date: 20Jul2022. Ae resulted in none of the above.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 09:00 as dose 1, single (Lot number: EN2606), in left arm, on 27May2021 as dose 2, single (Lot number: ER2613), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac disease" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM+D3; LYSINE. The following information was reported: VACCINATION FAILURE (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: Unknown results. Therapeutic measures were taken because of vaccination failure, covid-19 with paxlovid started on 05Jul2022 treatment stop date=09Jul2022.  Clinical course: Adverse event: None. Sore arm per usual. Patient was writing to say that patient have Paxlovid rebound and patient very disappointed to have another long quarantine. Please let others know this can happen. patient wouldn't have taken the drug if patient had known this earlier. Other medication in 2weeks product included Multivitamin, Calcium+D3, LLysine  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pain, Skin exfoliation, Vaccination site erythema, Vaccination site induration
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose number unknown (booster), single (Lot number: FM7553) for covid-19 immunization. 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 ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 29Jun2022, outcome "unknown" and all described as "it is like whole site red and a hard ball on the vaccinated area and so much hurting"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "unknown", described as "She cannot put her hand all the way up or down"; DRY SKIN (non-serious), SKIN EXFOLIATION (non-serious), outcome "unknown" and all described as "the patch looks like it is a dry and peeling off like skin is dry and peeling out"; PAIN (non-serious), outcome "unknown", described as "sometimes she did have pain". Additional information: The reporter reported for his/her mom. Reporter sent a picture to the provider and she said it was a reaction of the Pfizer.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose number unknown (booster), single (Lot number: FM7553) for covid-19 immunization. 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 ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 29Jun2022, outcome "unknown" and all described as "it is like whole site red and a hard ball on the vaccinated area and so much hurting"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "unknown", described as "She cannot put her hand all the way up or down"; DRY SKIN (non-serious), SKIN EXFOLIATION (non-serious), outcome "unknown" and all described as "the patch looks like it is a dry and peeling off like skin is dry and peeling out"; PAIN (non-serious), outcome "unknown", described as "sometimes she did have pain". Additional information: The reporter reported for his/her mom. Reporter sent a picture to the provider and she said it was a reaction of the Pfizer.  No follow-up attempts are possible. No further information is expected.
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, 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 72-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm, as dose number unknown, single (Batch/Lot number: unknown), in left arm and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid for COVID 19 Treatment. The treatment start date was 08Jul2022 and stop date was 12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm, as dose number unknown, single (Batch/Lot number: unknown), in left arm and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid for COVID 19 Treatment. The treatment start date was 08Jul2022 and stop date was 12Jul2022.  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: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 43-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 8737) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Unknown results; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years 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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: If vaccine received: Yes, Other medication in 2weeks: No, Known allergies: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blood lactate dehydrogenase, International normalised ratio, Intracardiac thrombus, Investigation, Metabolic function test
Clinical narrative: Thrombosis; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on [13Jul2022], this case now contains all required information to be considered valid.  This is a literature report.  A female patient in her 50's received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "end-stage heart failure" (unspecified if ongoing); "non ischemic dilated cardiomyopathy" (unspecified if ongoing); "implanted with a LVAD" (unspecified if ongoing), notes: implanted with a left ventricular assist device (LVAD) as bridge to transplant; "exchange from one model to different model" (unspecified if ongoing), notes: 10 days after admission. The patient's concomitant medications were not reported. Past drug history included: Aspirin, notes: 325 mg daily since implantation. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: INTRACARDIAC THROMBUS (hospitalization, medically significant, life threatening), 8 days after the suspect product(s) administration, outcome "not recovered", described as "Thrombosis". The event "thrombosis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood lactate dehydrogenase: above 3000; markedly elevated; 4458 IU/l, notes: peaked; International normalised ratio: 2.9; between 2.4 and 3.9, notes: 2 months preceding admission; power: elevated; continued to rise; exceeded 20 W; Metabolic function test: returned hemolyzed; Platelet count: less than 150, notes: before device exchange. Therapeutic measures were taken as a result of intracardiac thrombus.; Sender's Comments: Based on the known safety profile and  information in the case report, a casual association between reported event and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Platelet count
Clinical narrative: Thrombosis; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on [13Jul2022], this case now contains all required information to be considered valid.  This is a literature report.  A female patient in her 50's received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "end-stage heart failure" (unspecified if ongoing); "non ischemic dilated cardiomyopathy" (unspecified if ongoing); "implanted with a LVAD" (unspecified if ongoing), notes: implanted with a left ventricular assist device (LVAD) as bridge to transplant; "exchange from one model to different model" (unspecified if ongoing), notes: 10 days after admission. The patient's concomitant medications were not reported. Past drug history included: Aspirin, notes: 325 mg daily since implantation. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: INTRACARDIAC THROMBUS (hospitalization, medically significant, life threatening), 8 days after the suspect product(s) administration, outcome "not recovered", described as "Thrombosis". The event "thrombosis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood lactate dehydrogenase: above 3000; markedly elevated; 4458 IU/l, notes: peaked; International normalised ratio: 2.9; between 2.4 and 3.9, notes: 2 months preceding admission; power: elevated; continued to rise; exceeded 20 W; Metabolic function test: returned hemolyzed; Platelet count: less than 150, notes: before device exchange. Therapeutic measures were taken as a result of intracardiac thrombus.; Sender's Comments: Based on the known safety profile and  information in the case report, a casual association between reported event and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Candida test, Culture urine, Epstein-Barr virus antibody, Full blood count, Gardnerella test
Clinical narrative: reactive acute genital ulceration triggered by the SARS-CoV-2 vaccine; This is a literature report.  A 12-year-old otherwise-healthy female patient presented with painful vulvar ulcerations that had been present for approximately 5 days. Review of systems was positive for dysuria and hematuria. She was initially evaluated by her pediatrician and empirically treated with oral nitrofurantoin, fluconazole, and phenazopyridine for suspected urinary tract infection. She was then referred to pediatric dermatology for further evaluation and treatment due to lack of improvement. She was otherwise healthy and was not taking any other medications, denied any history of sexual activity, and had no previous history of oral ulcers, inflammatory bowel disease, or autoimmune disease. The family reported that the patient had received her second dose of the Pfizer-BioNTech SARS-CoV-2 vaccine approximately 48 hours before symptom onset. The day following vaccination, she also developed subjective fevers, fatigue, and malaise lasting 24 hours. On physical examination, there were approximately 2 _ 2-cm well-circumscribed, shallow ulcers with yellowish sloughing and purulent exudate on opposing surfaces of the bilateral labia minorae. Significant labial edema was present. Her oral mucosae were clear. Laboratory findings were notable for normal complete blood count and comprehensive metabolic panel and negative urine culture. Urinalysis demonstrated large leukocyte esterase, 20-29 white blood cells per high-power field, and moderate mucus. Lesional herpes simplex virus (HSV)-1 and HSV-2 polymerase chain reaction (PCR), Trichomonas/Gardnerella/Candida DNA probe, EBV antibody panel, respiratory viral panel, and SARS-CoV-2 PCR were negative. These clinical and laboratory findings were supportive of the diagnosis of reactive acute genital ulceration triggered by the SARS-CoV-2 vaccine. The patient was given topical clobetasol 0.05% ointment twice daily, lidocaine 2% jelly every 4-6 hours as needed, oral acetaminophen and ibuprofen as needed, and sitz baths with improvement of her symptoms. Ulcers healed over the course of 2 weeks.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  the reported event Genital ulceration cannot be completely excluded based on temporal association and known drug safety profile The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202200948342 Same article/drug/event and different patient (Patient 2);
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Genital ulceration, Herpes simplex, Herpes simplex test, Investigation, Metabolic function test
Clinical narrative: reactive acute genital ulceration triggered by the SARS-CoV-2 vaccine; This is a literature report.  A 12-year-old otherwise-healthy female patient presented with painful vulvar ulcerations that had been present for approximately 5 days. Review of systems was positive for dysuria and hematuria. She was initially evaluated by her pediatrician and empirically treated with oral nitrofurantoin, fluconazole, and phenazopyridine for suspected urinary tract infection. She was then referred to pediatric dermatology for further evaluation and treatment due to lack of improvement. She was otherwise healthy and was not taking any other medications, denied any history of sexual activity, and had no previous history of oral ulcers, inflammatory bowel disease, or autoimmune disease. The family reported that the patient had received her second dose of the Pfizer-BioNTech SARS-CoV-2 vaccine approximately 48 hours before symptom onset. The day following vaccination, she also developed subjective fevers, fatigue, and malaise lasting 24 hours. On physical examination, there were approximately 2 _ 2-cm well-circumscribed, shallow ulcers with yellowish sloughing and purulent exudate on opposing surfaces of the bilateral labia minorae. Significant labial edema was present. Her oral mucosae were clear. Laboratory findings were notable for normal complete blood count and comprehensive metabolic panel and negative urine culture. Urinalysis demonstrated large leukocyte esterase, 20-29 white blood cells per high-power field, and moderate mucus. Lesional herpes simplex virus (HSV)-1 and HSV-2 polymerase chain reaction (PCR), Trichomonas/Gardnerella/Candida DNA probe, EBV antibody panel, respiratory viral panel, and SARS-CoV-2 PCR were negative. These clinical and laboratory findings were supportive of the diagnosis of reactive acute genital ulceration triggered by the SARS-CoV-2 vaccine. The patient was given topical clobetasol 0.05% ointment twice daily, lidocaine 2% jelly every 4-6 hours as needed, oral acetaminophen and ibuprofen as needed, and sitz baths with improvement of her symptoms. Ulcers healed over the course of 2 weeks.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  the reported event Genital ulceration cannot be completely excluded based on temporal association and known drug safety profile The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202200948342 Same article/drug/event and different patient (Patient 2);