chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29Oct2023 to 03Nov2023.  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.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the events Drug ineffective and Covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300360590 same patient, different drug /event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Pennicillan" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from 27Oct2023 to 01Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360712 same patient, different drug/AE.;
Age: 69.0
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 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy"; Codeine, reaction(s): "Allergy"; Diflucan, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, 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 vaccination failure, covid-19 which included Paxlovid from 24Oct2023 to 28Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300361268 same patient different drug/event;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 66-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 12:45 as dose 1, single (Lot number: 00069-2362-10) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Subacute cutaneous Lupus" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 04 Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03 Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02 Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 01 Manufacturer unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 30Oct2023 to 04Nov2023).
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nervousness
Clinical narrative: Patient said she took two vaccines and two boosters all from Pfizer and for one of them, she passed out (blanked out); she was scared as it was pretty bad; 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.  An 84-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol; LOSARTAN taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Flu shot. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Patient said she took two vaccines and two boosters all from Pfizer and for one of them, she passed out (blanked out)"; NERVOUSNESS (non-serious), outcome "unknown", described as "she was scared as it was pretty bad". Clinical course: Patient said she took two vaccines and two boosters all from Pfizer and for one of them, she passed out (blanked out). About the new Booster shot (Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)), she wanted to know if she will experience passing out again. Patient stated she was scared as it was pretty bad and she did not know if she should get the new Covid booster. She would like to get it as she thought it can help her to avoid hospitalization, but she was scared. She got the flu shot but did not get the new Covid shot (She said she now got the Flu shot but did not get the new booster.). About height and weight: consumer stated, "It is about 5'8 and weight is about 200 pounds. I am trying to reduce."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Moderna, Dose: 4, 5 / Pfizer, Dose: 1-3; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL1284), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL1283), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 50 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Oct2022 as dose 4 (booster), single (Lot number: 056MZIA), in left arm and on 15May2023 as dose 5 (booster), single (Lot number: 5017H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild mitral valve prolapse" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Dose: 4, 5 / Pfizer, Dose: 1-3"; 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: (unspecified date) Positive, notes: Covid-19 treatment; (Nov2023) Positive, notes: Rebound - mild symptoms and positive test on day 12. This was after feeling better for about 4 days. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as covid treatment from 31Oct2023 to 04Nov2023.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HH7595), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV infection, long-term", start date: 1985 (ongoing); "bladder & Kidney cancer" (ongoing); "bladder & Kidney cancer" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna bivalent (Dose 6, single), administration date: 26Apr2023, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna bivalent (Dose 5, single), administration date: 19Sep2022, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna (Dose 4, single), administration date: 08Mar2022, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna (Dose 3, single), administration date: 01Sep2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna (Dose 2, single), administration date: 03Mar2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna (Dose 1, single), administration date: 03Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "Covid-19". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dehydration, Dizziness, Electrolyte imbalance
Clinical narrative: dehydrated; my electrolytes were messed up; dizziness; could hardly walk; my BP was high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset 06Oct2023, outcome "unknown", described as "could hardly walk"; DEHYDRATION (medically significant) with onset 06Oct2023, outcome "unknown", described as "dehydrated"; DIZZINESS (non-serious) with onset 06Oct2023, outcome "not recovered"; BLOOD PRESSURE INCREASED (non-serious) with onset 06Oct2023, outcome "unknown", described as "my BP was high"; ELECTROLYTE IMBALANCE (medically significant) with onset 06Oct2023, outcome "unknown", described as "my electrolytes were messed up". The events "dehydrated", "my electrolytes were messed up", "dizziness", "could hardly walk" and "my bp was high" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) high. Therapeutic measures were taken as a result of dehydration, electrolyte imbalance. Clinical course: patient went into dizziness 4 hours after receiving dose that patient could hardly walk. Patient had been done well with the other doses. Patient spent 4 hours in the ER, BP (blood pressure) was high and electrolytes were messed up. Patient was dehydrated. Paitent had an IV, magnesium and potassium in the ER. Patient have had dizziness ever since. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability
Clinical narrative: dehydrated; my electrolytes were messed up; dizziness; could hardly walk; my BP was high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset 06Oct2023, outcome "unknown", described as "could hardly walk"; DEHYDRATION (medically significant) with onset 06Oct2023, outcome "unknown", described as "dehydrated"; DIZZINESS (non-serious) with onset 06Oct2023, outcome "not recovered"; BLOOD PRESSURE INCREASED (non-serious) with onset 06Oct2023, outcome "unknown", described as "my BP was high"; ELECTROLYTE IMBALANCE (medically significant) with onset 06Oct2023, outcome "unknown", described as "my electrolytes were messed up". The events "dehydrated", "my electrolytes were messed up", "dizziness", "could hardly walk" and "my bp was high" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) high. Therapeutic measures were taken as a result of dehydration, electrolyte imbalance. Clinical course: patient went into dizziness 4 hours after receiving dose that patient could hardly walk. Patient had been done well with the other doses. Patient spent 4 hours in the ER, BP (blood pressure) was high and electrolytes were messed up. Patient was dehydrated. Paitent had an IV, magnesium and potassium in the ER. Patient have had dizziness ever since. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes abnormal, Blood potassium, Blood potassium decreased, Dehydration, Dizziness
Clinical narrative: dehydrated; my electrolytes were messed up; dizziness; could hardly walk; my BP was high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset 06Oct2023, outcome "unknown", described as "could hardly walk"; DEHYDRATION (medically significant) with onset 06Oct2023, outcome "unknown", described as "dehydrated"; DIZZINESS (non-serious) with onset 06Oct2023, outcome "not recovered"; BLOOD PRESSURE INCREASED (non-serious) with onset 06Oct2023, outcome "unknown", described as "my BP was high"; ELECTROLYTE IMBALANCE (medically significant) with onset 06Oct2023, outcome "unknown", described as "my electrolytes were messed up". The events "dehydrated", "my electrolytes were messed up", "dizziness", "could hardly walk" and "my bp was high" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) high. Therapeutic measures were taken as a result of dehydration, electrolyte imbalance. Clinical course: patient went into dizziness 4 hours after receiving dose that patient could hardly walk. Patient had been done well with the other doses. Patient spent 4 hours in the ER, BP (blood pressure) was high and electrolytes were messed up. Patient was dehydrated. Paitent had an IV, magnesium and potassium in the ER. Patient have had dizziness ever since. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extrasystoles, Fall, Fear of death, Gait inability, Head discomfort
Clinical narrative: dehydrated; my electrolytes were messed up; dizziness; could hardly walk; my BP was high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset 06Oct2023, outcome "unknown", described as "could hardly walk"; DEHYDRATION (medically significant) with onset 06Oct2023, outcome "unknown", described as "dehydrated"; DIZZINESS (non-serious) with onset 06Oct2023, outcome "not recovered"; BLOOD PRESSURE INCREASED (non-serious) with onset 06Oct2023, outcome "unknown", described as "my BP was high"; ELECTROLYTE IMBALANCE (medically significant) with onset 06Oct2023, outcome "unknown", described as "my electrolytes were messed up". The events "dehydrated", "my electrolytes were messed up", "dizziness", "could hardly walk" and "my bp was high" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) high. Therapeutic measures were taken as a result of dehydration, electrolyte imbalance. Clinical course: patient went into dizziness 4 hours after receiving dose that patient could hardly walk. Patient had been done well with the other doses. Patient spent 4 hours in the ER, BP (blood pressure) was high and electrolytes were messed up. Patient was dehydrated. Paitent had an IV, magnesium and potassium in the ER. Patient have had dizziness ever since. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Investigation
Clinical narrative: dehydrated; my electrolytes were messed up; dizziness; could hardly walk; my BP was high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset 06Oct2023, outcome "unknown", described as "could hardly walk"; DEHYDRATION (medically significant) with onset 06Oct2023, outcome "unknown", described as "dehydrated"; DIZZINESS (non-serious) with onset 06Oct2023, outcome "not recovered"; BLOOD PRESSURE INCREASED (non-serious) with onset 06Oct2023, outcome "unknown", described as "my BP was high"; ELECTROLYTE IMBALANCE (medically significant) with onset 06Oct2023, outcome "unknown", described as "my electrolytes were messed up". The events "dehydrated", "my electrolytes were messed up", "dizziness", "could hardly walk" and "my bp was high" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) high. Therapeutic measures were taken as a result of dehydration, electrolyte imbalance. Clinical course: patient went into dizziness 4 hours after receiving dose that patient could hardly walk. Patient had been done well with the other doses. Patient spent 4 hours in the ER, BP (blood pressure) was high and electrolytes were messed up. Patient was dehydrated. Paitent had an IV, magnesium and potassium in the ER. Patient have had dizziness ever since. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Indication: Covid; Indication: Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "nerve pain" (unspecified if ongoing); "Neuropathy" (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 "unknown" and all described as "Indication: Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Prior Vaccinations (within 4 weeks) was No.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: 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 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 19:45 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE, Vaccine location: Left arm), administration date: Oct2022, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2023) Positive; (21Oct2023) Negative; (23Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 30Oct2023 to 04Nov2023.  Additional information: No Known allergies. No Other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash is on his legs, arms, and back; It also itches and itches.; 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 29Sep2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleeping pill" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for insomnia (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, 1st dose: , Date: 01Feb2021, Time: Unknown , Anatomical Site of injection: Administered in right arm, Route of Administration: Not provided, Batch/Lot number: EL3248), administration date: 01Feb2021, when the patient was 75-year-old, for Covid-19 Immunization; bnt162b2 (DOSE 2, SINGLE, 2nd dose: , Date: 20Mar2021, Time: Unknown , Anatomical Site of injection: Administered in arm, unknown which arm ., Batch/Lot number:EN6200), administration date: 20Mar2021, when the patient was 75-year-old, for Covid-19 Immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 01Oct2021, outcome "not recovered", described as "It also itches and itches."; RASH (non-serious) with onset 01Oct2021, outcome "not recovered", described as "Rash is on his legs, arms, and back". The events "rash is on his legs, arms, and back" and "it also itches and itches." required physician office visit. Therapeutic measures were taken as a result of rash, rash pruritic.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362828 Same patient, same drug/different dose, different event;US-PFIZER INC-202300362835 Same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: dont feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer), Program ID:. The reporter is the patient. A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "dont feel good". Additional information: It was reported that the patient dont feel good and she was asking how far apart she should take the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: if I had had a different vaccine I may not have gotten Covid; if I had had a different vaccine I may not have gotten Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "if I had had a different vaccine I may not have gotten Covid". Clinical course: The reporter considered event was caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Chronic obstructive pulmonary disease
Clinical narrative: asthma; COPD; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". Additional information: Patient called in seeking assistance with the ABRYSVO vaccine. During the call patient stated, "I've got all of Pfizer's Covid vaccines." Patient later stated on the call, "I have COPD and asthma."   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Started losing hair on his legs and a short time later he began losing the hair on his head / He now is bald; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jul2023 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: ALOPECIA (non-serious), outcome "unknown", described as "Started losing hair on his legs and a short time later he began losing the hair on his head / He now is bald".  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
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: We both did come down with Covid-19 4 week's ago; We both did come down with Covid-19 4 week's ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had gotten all 3 of the Covid-19 shots last year ending with the booster in Nov2022. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "We both did come down with Covid-19 4 week's ago". The patient did come down with Covid-19 4 week's ago just 5 days after getting the high strength flu shot that doctor's give the elderly. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300361856 same reporter/drug/event different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: having COVID/previous administration of Pfizer COVID-19 vaccine; having COVID/previous administration of Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "having COVID/previous administration of Pfizer COVID-19 vaccine". Clinical course: Caller wanted to know if when can she revaccinated after having COVID. There's a previous administration of Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid/began serious symptoms late 07Nov2023; tested positive for Covid/tested positive for Covid/began serious symptoms late 07Nov2023; a slightly sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 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 Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "a slightly sore arm"; VACCINATION FAILURE (medically significant) with onset 07Nov2023, outcome "unknown", described as "tested positive for Covid/began serious symptoms late 07Nov2023"; COVID-19 (medically significant) with onset 07Nov2023, outcome "unknown", described as "tested positive for Covid/tested positive for Covid/began serious symptoms late 07Nov2023". The events "tested positive for covid/began serious symptoms late 07nov2023" and "tested positive for covid/tested positive for covid/began serious symptoms late 07nov2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2023) Positive. The patient received booster Oct2023 with no side effects as usual other than a slightly sore arm. On 08Nov2023 the patient tested positive for Covid, the patient began serious symptoms late 07Nov2023 but by 08Nov2023 afternoon when the patient saw the dr the patient was only showing mild symptoms, no fever ever, so the patient was still grateful. Those the patient was close to during incubation period all tested negative.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myelitis, Spinal cord injury
Clinical narrative: spinal cord injury with huge inflammation, somehow it moved outside my body into air; spinal cord injury with huge inflammation, somehow it moved outside my body into air; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPINAL CORD INJURY (life threatening), MYELITIS (life threatening), outcome "unknown" and all described as "spinal cord injury with huge inflammation, somehow it moved outside my body into air". Clinical course: Patient reported, "I need help!!! Your shot has created a monster of an out of controlled substance outside my body!! I have a spinal cord injury with huge inflammation., somehow it moved outside my body into air!!! I can't explain in a text !! I need someone to call me ASAP!! Or I'm going to hv to call the news!! I can't get help with drs! I'm not crazy I can prove that & a lie detective !!! Plz plz some one call me Your think tank dept, Scientist or someone with brains This is going to kill me if I don't get".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoacusis, Vasculitis, Visual impairment
Clinical narrative: she had a problem with her hearing, eyesight and even with walking; she had a problem with her hearing, eyesight and even with walking; she had a problem with her hearing, eyesight and even with walking; She was diagnosed with Vasculitis disease; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), VISUAL IMPAIRMENT (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "she had a problem with her hearing, eyesight and even with walking"; VASCULITIS (non-serious), outcome "unknown", described as "She was diagnosed with Vasculitis disease". Additional information: a consumer, would like to know if there is any other clinical testing that has affected Vasculitis disease. She mentioned that she got the Pfizer covid-19 booster. She mentioned that she had a problem with her hearing, eyesight and even with walking. She was diagnosed with Vasculitis disease and her doctor said that she was exposed to something the reason why she got the disease.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive. Clinical course: The patient got a covid vaccine she tested positive and now wanted to know when she can take the booster after tested positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Malaise, Pain
Clinical narrative: achy; isn't feeling great/feeling 'run down'; Initial information was received on 31-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case is linked to case 2023SA342246.  This case involves 58 years old female patient who experienced achy and isn't feeling great/feeling 'run down' after receiving COVID-19 VACCINE , pneumonia vaccine and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site and also received a unknown dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for COVID-19 immunization. The information on batch number was requested.  On an unknown date the patient developed achy (pain) and isn't feeling great/feeling 'run down' (malaise) (unknown latency) following the administration of influenza vaccine and COVID-19 VACCINE.  It is unknown if there were lab data/results available.   Reportedly "Caller reports she is scheduled to give her dose of Dupixent today, but she is going to delay by a few days because she isn't feeling great. Patient stated she had her COVID booster, flu vaccine and pneumonia vaccine given at the same time yesterday and is feeling 'run down' and achy. She is utilizing Tylenol as needed which helps. Patient reports her skin is 'completely cleared'. "  Action taken was not applicable.  The patient was treated with paracetamol (Tylenol A).  At time of reporting, the outcome was Unknown for both the events.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Pyrexia
Clinical narrative: woke up with a fever; diagnosed with influenza; Initial information received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 9 years old female patient who woke up with a fever and diagnosed with influenza after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Oct-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dosage, expiry date, lot number- not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). Information on the batch number was requested.  On 30-OCT-2023 the patient developed woke up with a fever (pyrexia) (latency- 3 days) following the administration of influenza vaccine.  In 2023 the patient developed diagnosed with influenza (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments:  US-SA-2023SA283904:Same patient