chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Chest discomfort, Dizziness, Pyrexia, SARS-CoV-2 test
Clinical narrative: Novavax booster received on 18-OCT-2023; New positive test; COVID-19; New positive test; Dizziness; Chest tightness; 101.0 fever; On 18-DEC-2023, this serious initial spontaneous safety report was received from an other reporter via a pharmaceutical company, and was received by Novavax on 05-JAN-2024.   An individual of an unspecified race, age and sex was vaccinated with intramuscular use Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine dose 1 (booster) in the right arm on 18-OCT-2023 at 12:00.  The following medical history was reported: Hypersensitivity.  No concomitant medications were reported.  On 18-OCT-2023, the individual experienced vaccination failure (PT: Vaccination failure) (Serious: Medically Significant).  On an unspecified day in NOV-2023, after vaccination, the individual experienced COVID-19 after being vaccinated with Novavax on 18-OCT-2023 (PT: Breakthrough COVID-19). The individual was treated for COVID-19 with Paxlovid (nirmatrelvir, ritonavir) from 27-NOV-2023 until 01-DEC-2023. On 17-DEC-2023 06:00, 1 month 27 days 18 hours after vaccination, the individual had a new positive test, with far worse symptoms: 101.0 fever (PT: Pyrexia), dizziness (PT: Dizziness), and chest tightness (PT: Chest discomfort).  Relevant lab tests included: SARS-CoV-2 test (Result: Negative; 07-DEC-2023, day 11) and SARS-CoV-2 test (Result: Positive; 17-DEC-2023).  On 18-OCT-2023, the event of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Breakthrough COVID-19, Pyrexia, Dizziness, and Chest discomfort were not recovered/not resolved.  Lot number was not provided in the report.; Sender's Comments: This individual of an unspecified age and sex experienced: Vaccination failure, Breakthrough COVID-19, Chest discomfort, Dizziness and Pyrexia after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Vaccination failure was assessed as serious. The events Breakthrough COVID-19, Chest discomfort, Dizziness and Pyrexia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Novavax booster received on 18-OCT-2023; New positive test; COVID-19; New positive test; Dizziness; Chest tightness; 101.0 fever; On 18-DEC-2023, this serious initial spontaneous safety report was received from an other reporter via a pharmaceutical company, and was received by Novavax on 05-JAN-2024.   An individual of an unspecified race, age and sex was vaccinated with intramuscular use Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine dose 1 (booster) in the right arm on 18-OCT-2023 at 12:00.  The following medical history was reported: Hypersensitivity.  No concomitant medications were reported.  On 18-OCT-2023, the individual experienced vaccination failure (PT: Vaccination failure) (Serious: Medically Significant).  On an unspecified day in NOV-2023, after vaccination, the individual experienced COVID-19 after being vaccinated with Novavax on 18-OCT-2023 (PT: Breakthrough COVID-19). The individual was treated for COVID-19 with Paxlovid (nirmatrelvir, ritonavir) from 27-NOV-2023 until 01-DEC-2023. On 17-DEC-2023 06:00, 1 month 27 days 18 hours after vaccination, the individual had a new positive test, with far worse symptoms: 101.0 fever (PT: Pyrexia), dizziness (PT: Dizziness), and chest tightness (PT: Chest discomfort).  Relevant lab tests included: SARS-CoV-2 test (Result: Negative; 07-DEC-2023, day 11) and SARS-CoV-2 test (Result: Positive; 17-DEC-2023).  On 18-OCT-2023, the event of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Breakthrough COVID-19, Pyrexia, Dizziness, and Chest discomfort were not recovered/not resolved.  Lot number was not provided in the report.; Sender's Comments: This individual of an unspecified age and sex experienced: Vaccination failure, Breakthrough COVID-19, Chest discomfort, Dizziness and Pyrexia after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Vaccination failure was assessed as serious. The events Breakthrough COVID-19, Chest discomfort, Dizziness and Pyrexia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Age: 0.58
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: HCP reported a dose of PEDVAX HIB was administered to a patient on 12/18/2023 after a TE that also occurred on 12/18/2023.  The TE evaluation resulted in a "not supported" outcome.  No adverse side effects or issues were experienced by the patient af; HCP reported a dose of PEDVAX HIB was administered to a patient on 12/18/2023 after a TE that also occurred on 12/18/2023.  The TE evaluation resulted in a "not supported" outcome.  No adverse side effects or issues were experienced by the patient af; Information has been received from a nurse practitioner, referring to a 7 months-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-DEC-2023, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscularly, 0.5 milliliter, once, lot number reported as "X00754" and expiration date reported on "20-NOV-2025", administered for prophylaxis (strength, lot #, and route of administration were not provided).   The reporter stated that the temperate excursion (TE) of the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) occurred on the same date of administration (on 18-DEC-2023).  The TE evaluation resulted in a "not supported" outcome. It was confirmed that no adverse side effects or issues were experienced by the patient after the administered dose.  The vaccine had a temperature excursions of 18.8 Fahrenheit (F), during a time frame of 1 hour 25 minutes. It was confirmed that non previous temperature excursion occurred.; Sender's Comments:  US-009507513-2312USA007879:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm. The pain is short of stabbing or burning; it's a sharp; burning and stabbing in the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (primary immunization series completed.), for COVID-19 immunization; Flu shot, for immunization, reaction(s): "no adverse effect". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm. The pain is short of stabbing or burning; it's a sharp"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning and stabbing in the injection site".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Underdose
Clinical narrative: may be like 0.1 max of the full dose was made into her muscle that most of it just dribbled out on her arms; may be like 0.1 max of the full dose was made into her muscle that most of it just dribbled out on her arms; may be like 0.1 max of the full dose was made into her muscle that most of it just dribbled out on her arms; not even half the dose was given; This is a spontaneous report received from a Pharmacist and a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM7645, Expiration Date: 28Feb2025) for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE DISCHARGE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), outcome "unknown" and all described as "may be like 0.1 max of the full dose was made into her muscle that most of it just dribbled out on her arms"; UNDERDOSE (non-serious), outcome "unknown", described as "not even half the dose was given". Additional information: The patient started to move the arm when the vaccine was administered, and it felt that not even half the dose was given. The arm was moved during the injection for Abrysvo and they think the patient did not get the full dose, probably not even a half a dose. The patient moved their arm during the injection or moved their arms started to administered it in, the patient moved their arm and that, not a full dose to be given. The patient did move and she believes that may be like 0.1 max of the full dose was made into her muscle that most of it just dribbled out on her arms. They asked if there are any recommendations on how to proceed. The reporting pharmacist considered the event as non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "cancer survivor" (unspecified if ongoing), notes: Other medical history: cancer survivor; "obesity" (unspecified if ongoing), notes: Other medical history: obesity; "MRI contrast dye" (unspecified if ongoing), notes: Known allergies: MRI contrast dye. 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from an Other HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Nov2021 as dose number unknown (booster), single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing); "known allergies: animals" (unspecified if ongoing); "known allergies: fruit extracts" (unspecified if ongoing); "known allergies: mold" (unspecified if ongoing); "known allergies: dust" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Nov2021, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2023) Negative; (23Dec2023) Negative; (30Dec2023) Positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 19Dec2023 to 23Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 29-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MESALAMINE. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for covid 19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures, Paxlovid from 20Dec2023 to 24Dec2023, were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid from 21Dec2023 to 25Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
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 Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 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: Covid-19 vaccine (Dose 5; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1; Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2023 at 17:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2023) Positive; (24Dec2023) Positive; (25Dec2023) Negative; (26Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID-19 treatment with Paxlovid TB from 21Dec2023 till 26Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Seasonal allergies only" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Positive test after 3 days and two  negative tests; (2023) negative, notes: Positive test after 3 days and two  negative tests; (2023) negative, notes: Positive test after 3 days and two  negative tests. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 08:00 as dose 1, single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes Type 2" (unspecified if ongoing); "Atherosclerosis of Aorta" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Unknown Manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Unknown Manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid.  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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Rebound COVID; Rebound COVID; This is a spontaneous report received from a Consumer or other non HCP. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.1 (vaccine location: Left arm), administration date: 19Oct2022, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound COVID". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid treatment; covid treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); 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 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Posititve. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid from 23Dec2023 to 27Dec2023.  No follow-up attempts are possible.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: The patient recevied Paxlovid; The patient recevied Paxlovid; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 12May2023. Vaccination history included: Covid-19 vaccine (DOSE 1, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" and all described as "The patient recevied Paxlovid". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient received treatment with paxlovid from 19Dec2023 to 23Dec2023 for COVID-19.  No follow-up attempts are possible.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 as dose 1, single at the age of 58 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: moderna (DOSE NUMBER UNKNOWN, SINGLE, Vaccine location: Left arm), administration date: 21Oct2022, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid from 21Dec2023 to 25Dec2023.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 12:00 as dose 1, single at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codein, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 70.0
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 Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies food: salmon" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective as patient received Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: periods stopped; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) at the age of 44 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious) with onset 01Feb2023, outcome "recovered", described as "periods stopped". Therapeutic measures were not taken as a result of amenorrhoea.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient discussed she had regular periods and menstruation until taking the vaccine. Her periods stopped post vaccine and very close in proximation to being administered vaccine. The adverse event did not result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The event did not require hospitalization.   Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "known_allergies: shellfish" (unspecified if ongoing), notes: known_allergies: shellfish; "obesity" (unspecified if ongoing); "known_allergies: shellfish, fungi, molds" (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; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was taken from 20Dec2023 to 24Dec2023  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. 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, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". 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 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 at 12:00 as dose 1, single (Lot number: HF9299), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroid; "obesity" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 05, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient received Paxlovid from 21Dec2023 to 27Dec2023 (Lot number: GY1962) for treatment of COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Nov2023 at 18:00 as dose 1, single (Batch/Lot number: unknown), 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: 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; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 18Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure. Paxlovid was taken from 18Dec2023 to 26Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 12:00 as dose 1, single at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.  No follow-up attempts are possible.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe pain in my joints, both small and large, including joints in my shoulders, elbows, fingers and knees / now I'm on wheelchair and need to be taken care of by others; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (DOSE 1), administration date: 2021, for COVID-19 immunization. The following information was reported: ARTHRALGIA (disability), outcome "not recovered", described as "severe pain in my joints, both small and large, including joints in my shoulders, elbows, fingers and knees / now I'm on wheelchair and need to be taken care of by others". Therapeutic measures were taken as a result of arthralgia. The patient had been seeking treatment for the pain for over 2 years without any success. The patient was able to live independently before the vaccine. The patient described the pain as "disabling pain".  The lot number for BNT162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: NEVER had a single side in effect other than the expected site injection sites.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 73-year-old 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. Past drug history included: Fentanyl for chronic pain, notes: patches. The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "NEVER had a single side in effect other than the expected site injection sites.".  Additional information: The patient reported that they have every vaccine that was available for every type of protection, not just Covid. She has had up to 4 various vaccines at once and have never had a single side in effect other than the expected site injection sites.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a consumer.  A 50-year-old male patient received BNT162b2 (BNT162B2 NOS), on 15Oct2022 at 03:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for COVID-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 28Oct2023 at 02:00 as dose number unknown, single), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2023 at 02:00, outcome "recovered with sequelae"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered with sequelae" and all described as "COVID-19". Therapeutic measures were taken as a result of the events Drug ineffective and COVID-19 which included nirmatrelvir/ritonavir (PAXLOVID) from 25Dec2023 to 29Dec2023 as antiviral treatment.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Sep2023 as dose number unknown, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "allergies sulfas" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Drug allergies: Erythromycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 25Dec2023 to 30Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Death, Pneumonia, Weight
Clinical narrative: pneumonia; heart issue; passed away; This is a spontaneous report received from a Consumer or other non HCP.  A 90-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Dec2023 at 12:44 as dose 1, single (Batch/Lot number: unknown) at the age of 90 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (hospitalization) with onset Dec2023, outcome "unknown", described as "heart issue"; PNEUMONIA (hospitalization) with onset Dec2023, outcome "unknown"; DEATH (death) with onset 01Jan2024, outcome "fatal", described as "passed away". The clinical course was reported as follows: The next day after vaccination, the patient had breathing problems which progressed, had to call emergency line, and the patient was taken to hospital locally. The patient came into the hospital with pneumonia and suspected there was a heart issue going on, myocardio something (as reported). The patient was in the room, then went to go use the bathroom with an aide and apparently, she collapsed and there was no pulse and patient passed away. They tried to resuscitate the patient for 10 to 15 minutes but was unsuccessful. The cause of death is unknown, the reporter asked doctor and doctor could not determine, they indicated it could be a blood clot or heart attack. The patient underwent the following laboratory tests and procedures: Weight: Probably 125 or 130 pounds. The patient date of death was 01Jan2024. The reported cause of death was unknown. No autopsy was performed.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19, 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 Consumer or other non HCP .  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: GJ3275), in right arm and on 18May2023 as dose 6 (booster), single (Lot number: GJ6796), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6202), in right arm, on 03Apr2021 as dose 2, single (Lot number: EW0150), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Oct2023 at 11:15 as dose 7 (booster), single (Lot number: AU3921B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer (lumpectomy, radiation)", start date: 2018 (unspecified if ongoing); "breast cancer (lumpectomy, radiation)", start date: 2018 (unspecified if ongoing); "breast cancer (lumpectomy, radiation)", start date: 2018 (unspecified if ongoing); "lymphedema (left arm after radiation)/lymphedema (right and left legs)" (unspecified if ongoing), notes: lymphedema (left arm after radiation)/lymphedema (right and left legs); "obesity" (unspecified if ongoing); "Severe spinal stenosis" (unspecified if ongoing), notes: Severe spinal stenosis; "torn meniscus (both knees)" (unspecified if ongoing), notes: torn meniscus (both knees). Concomitant medication(s) included: DILTIAZEM, start date: 10Dec2008; ANASTROZOLE, start date: 06Sep2018; DICLOFENAC, start date: 27Feb2004; NATURE'S BOUNTY CALCIUM WITH VITAMIN D3, start date: 14Mar2023; NORDIC NATURALS ULTIMATE OMEGA, start date: 16Feb2018; KIRKLAND SIGNATURE TRIPLE ACTION JOINT HEALTH, start date: 27Feb2004. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 21Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2023) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cellulitis, Magnetic resonance imaging, Mammogram, Sepsis
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP .  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: GJ3275), in right arm and on 18May2023 as dose 6 (booster), single (Lot number: GJ6796), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6202), in right arm, on 03Apr2021 as dose 2, single (Lot number: EW0150), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Oct2023 at 11:15 as dose 7 (booster), single (Lot number: AU3921B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer (lumpectomy, radiation)", start date: 2018 (unspecified if ongoing); "breast cancer (lumpectomy, radiation)", start date: 2018 (unspecified if ongoing); "breast cancer (lumpectomy, radiation)", start date: 2018 (unspecified if ongoing); "lymphedema (left arm after radiation)/lymphedema (right and left legs)" (unspecified if ongoing), notes: lymphedema (left arm after radiation)/lymphedema (right and left legs); "obesity" (unspecified if ongoing); "Severe spinal stenosis" (unspecified if ongoing), notes: Severe spinal stenosis; "torn meniscus (both knees)" (unspecified if ongoing), notes: torn meniscus (both knees). Concomitant medication(s) included: DILTIAZEM, start date: 10Dec2008; ANASTROZOLE, start date: 06Sep2018; DICLOFENAC, start date: 27Feb2004; NATURE'S BOUNTY CALCIUM WITH VITAMIN D3, start date: 14Mar2023; NORDIC NATURALS ULTIMATE OMEGA, start date: 16Feb2018; KIRKLAND SIGNATURE TRIPLE ACTION JOINT HEALTH, start date: 27Feb2004. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 21Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2023) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.