chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Brain fog, Disorientation, Dizziness postural, Fatigue
Clinical narrative: chronic fatigue; chronic headaches; autonomic dysfunction/brain fog/develped sleep issues; Plaintiff struggles to do his job and go to school because of his symptoms; Information has been received from a lawyer regarding a case in litigation and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-MAY-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, for prophylaxis (strength, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date in May 2020 (also reported as following vaccination), the patient begun having fatigue, headaches, and dizziness when he stood up. Also developed sleep issues including insomnia, fitfulness, disorientation, seizure-like shaking, and night tremors. As the months progressed, so did the symptoms. He was seen by multiple physicians and specialists for his complains. As result of his post-Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, he had been unable to engage in normal activities that a normal young person would enjoy. He struggled to do his job and go to school. Bases upon his chronic and severe post- Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, patient had been diagnosed with various medical conditions, including but limited to, chronic fatigue, chronic headaches, brain fog, and autonomic dysfunction. As a proximate result of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the patient had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. Patient also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). As a direct and proximate result of his Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)-induced injuries, patient had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and he would continue to incur these losses and expenses in the future. At the time of reporting, the patient had not recovered from the events.  The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).   The reporter considered the events chronic fatigue, chronic headaches, and autonomic dysfunction to be Disability.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Impaired work ability, Insomnia, Loss of personal independence in daily activities, Seizure like phenomena
Clinical narrative: chronic fatigue; chronic headaches; autonomic dysfunction/brain fog/develped sleep issues; Plaintiff struggles to do his job and go to school because of his symptoms; Information has been received from a lawyer regarding a case in litigation and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-MAY-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, for prophylaxis (strength, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date in May 2020 (also reported as following vaccination), the patient begun having fatigue, headaches, and dizziness when he stood up. Also developed sleep issues including insomnia, fitfulness, disorientation, seizure-like shaking, and night tremors. As the months progressed, so did the symptoms. He was seen by multiple physicians and specialists for his complains. As result of his post-Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, he had been unable to engage in normal activities that a normal young person would enjoy. He struggled to do his job and go to school. Bases upon his chronic and severe post- Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, patient had been diagnosed with various medical conditions, including but limited to, chronic fatigue, chronic headaches, brain fog, and autonomic dysfunction. As a proximate result of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the patient had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. Patient also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). As a direct and proximate result of his Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)-induced injuries, patient had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and he would continue to incur these losses and expenses in the future. At the time of reporting, the patient had not recovered from the events.  The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).   The reporter considered the events chronic fatigue, chronic headaches, and autonomic dysfunction to be Disability.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Sleep disorder, Tremor
Clinical narrative: chronic fatigue; chronic headaches; autonomic dysfunction/brain fog/develped sleep issues; Plaintiff struggles to do his job and go to school because of his symptoms; Information has been received from a lawyer regarding a case in litigation and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-MAY-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, for prophylaxis (strength, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date in May 2020 (also reported as following vaccination), the patient begun having fatigue, headaches, and dizziness when he stood up. Also developed sleep issues including insomnia, fitfulness, disorientation, seizure-like shaking, and night tremors. As the months progressed, so did the symptoms. He was seen by multiple physicians and specialists for his complains. As result of his post-Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, he had been unable to engage in normal activities that a normal young person would enjoy. He struggled to do his job and go to school. Bases upon his chronic and severe post- Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, patient had been diagnosed with various medical conditions, including but limited to, chronic fatigue, chronic headaches, brain fog, and autonomic dysfunction. As a proximate result of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the patient had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. Patient also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). As a direct and proximate result of his Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)-induced injuries, patient had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and he would continue to incur these losses and expenses in the future. At the time of reporting, the patient had not recovered from the events.  The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).   The reporter considered the events chronic fatigue, chronic headaches, and autonomic dysfunction to be Disability.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of expired MMR-II to a patient.; This spontaneous report was received from a physician and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 24-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, recombinant Human albumin (rHA), administered for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) (lot number W001520 has been verified to be a valid lot number, expiration date reported and validated as 13-JAN-2024) (expired product administered). No additional adverse event was reported.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration; a TE for GARDASIL 9 in which the vaccines had also been administered to a patient; This spontaneous report was received from a Medical assistant, referring to a 15-year-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On 10-JAN-2024, the patient was vaccinated with a vaccine involved in a temperature excursion for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product storage error) injection, at a dose of 0.5 milliliter, administered for prophylaxis (lot #X019196 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) expiration date was reported and upon internal validation has been established as: 25-APR-2025; vaccination scheme, anatomical location of vaccination, strength, and route of administration were not provided). Excursion initiated in 04-DEC-2023, with a temperature of 54.3 Fahrenheit (F) for 9 hours and 32 minutes; on 05-DEC-2023, with a temperature of 57.7 F for 15 hours and 30 minutes; on 06-DEC-2023, with a temperature of 50.2 F for 5 hours; on 07-DEC-2023, with a temperature of 30.6 F for 1 hour and 55 minutes and at 52.7 F for 11 hours and 3 minutes; on 11-DEC-2023, with a temperature of 48.4 F for 1 hour and 47 minutes. The patient did not report any adverse issues or side effects from the administration (no adverse event).  This is one of 28 cases from the same reporter. ; Sender's Comments:  US-009507513-2401USA015310: US-009507513-2401USA015367: US-009507513-2401USA015363: US-009507513-2401USA015453: US-009507513-2401USA015454: US-009507513-2401USA015463: US-009507513-2401USA015498: US-009507513-2401USA015507: US-009507513-2401USA015517: US-009507513-2401USA015540: US-009507513-2401USA015557: US-009507513-2401USA015591: US-009507513-2401USA015605: US-009507513-2401USA015622: US-009507513-2401USA015627: US-009507513-2401USA015649: US-009507513-2401USA015651: US-009507513-2401USA015674: US-009507513-2401USA015687: US-009507513-2401USA015695: US-009507513-2401USA015699: US-009507513-2401USA015710: US-009507513-2401USA015731: US-009507513-2401USA015739: US-009507513-2401USA015760: US-009507513-2401USA015762:
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: any adverse issues or side effects; a TE for PEDVAX HIB in which the vaccines had also been administered to a patient; This spontaneous report was received from a Medical assistant, referring to a 12-month-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On 12-JAN-2024, the patient was vaccinated with a vaccine involved in a temperature excursion for  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (product storage error) intramuscular injection, at a dose of 0.5 milliliter, administered for prophylaxis (lot #X003664 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) expiration date was reported and upon internal validation has been established as: 10-NOV-2025; vaccination scheme, anatomical location of vaccination, strength, and route of administration were not provided). Excursion initiated in 04-DEC-2023, with a temperature of 54.3 Fahrenheit (F) for 9 hours and 32 minutes; on 05-DEC-2023, with a temperature of 57.7 F for 15 hours and 30 minutes; on 06-DEC-2023, with a temperature of 50.2 F for 5 hours; on 07-DEC-2023, with a temperature of 30.6 F for 1 hour and 55 minutes and at 52.7 F for 11 hours and 3 minutes; on 11-DEC-2023, with a temperature of 48.4 F for 1 hour and 47 minutes. The patient did not report any adverse issues or side effects from the administration (no adverse event).  This is one of 28 cases from the same reporter.; Sender's Comments:  US-009507513-2401USA015432: US-009507513-2401USA015454: US-009507513-2401USA015310: US-009507513-2401USA015367: US-009507513-2401USA015363: US-009507513-2401USA015453: US-009507513-2401USA015498: US-009507513-2401USA015507: US-009507513-2401USA015517: US-009507513-2401USA015540: US-009507513-2401USA015557: US-009507513-2401USA015591: US-009507513-2401USA015605: US-009507513-2401USA015622: US-009507513-2401USA015627: US-009507513-2401USA015649: US-009507513-2401USA015651: US-009507513-2401USA015674: US-009507513-2401USA015687: US-009507513-2401USA015695: US-009507513-2401USA015699: US-009507513-2401USA015710: US-009507513-2401USA015731: US-009507513-2401USA015739: US-009507513-2401USA015760: US-009507513-2401USA015762:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration; TE for GARDASIL 9 in which the vaccines had also been administered to a patient; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-JAN-2024, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, 0.5 milliliter, once, lot #X019196, expiration date: 25-APR-2025, administered for prophylaxis (strength, anatomical location, and route of administration were not provided). However, the administered dose experienced a temperature excursion (Product storage error) as follows:  Excursions: 04-DEC-2023: 54.3 degree Fahrenheit (F) for 9 hours 32 minutes 0 seconds 05-DEC-2023: 57.7F for 15 hours 30 minutes 0 seconds 06-DEC-2023: 50.2F for 5 hours 43 minutes 0 seconds 07-DEC-2023: 30.6F for 1 hour 55 minutes 0 seconds 07-DEC-2023: 52.7F for 11 hours 3 minutes 0 seconds 11-DEC-2023: 48.4F for 1 hour 47 minutes 0 seconds No other reported current or previous temperature excursions  The patient did not report any adverse issues or side effects from the administration.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015432:
Age: 1.08
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration.; TE for PEDVAX HIB and ROTATEQ in which the vaccines had also been administered to a patient on 12/07/2023.; TE for PEDVAX HIB and ROTATEQ in which the vaccines had also been administered to a patient on 12/07/2023.; This spontaneous report was received from a medical assistant referring to a 13-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 07-DEC-2023, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection (0.5 ml/ once, lot#: X003664, expiration date: 10-NOV-2025; strength and route of administration were not provided); and rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (1 dose, lot#: 1965644, expiration date: 02-OCT-2024; strength was not provided) orally by health professional for prophylaxis (product administered to patient of inappropriate age). The administered vaccines experienced temperature excursion (TE) at 54.3F for 9 hours 32 minutes on 04-DEC-2023, 57.7F for 15 hours 30 minutes on 05-DEC-2023, 50.2F for 5 hours 43 minutes on 06-DEC-2023, 30.6F for 1 hour 55 minutes and 52.7F for 11 hours 3 minutes on 07-DEC-2023, 48.4F for 1 hour 47 minutes on 11-DEC-2023 (product storage error). No other reported current or previous temperature excursions. The patient did not report any adverse issues or side effects from the administration (no adverse event).; Sender's Comments:  US-009507513-2401USA015432: US-009507513-2401USA015454: US-009507513-2401USA015463:
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: The product was administered to one patient following the excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 39-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis.   On 19-JAN-2024, the patient received Fluarix Quadrivalent 2023-2024 season .5 ml. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: The product was administered to one patient following the excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-JAN-2024 The nurse reported that Fluarix Quadrivalent vaccines (10 PFS carton) went out of range for 4 days, and were exposed to a maximum temperature of 54 Fahrenheit. The product was administered to one patient following the excursion, which led to incorrect storage of drug.  At the time of reporting, the dose has not been repeated. The reporter did not had the dose lot number information. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Pain in jaw
Clinical narrative: jaw pain; This is a spontaneous report received from a Pharmacist from medical information team.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN JAW (non-serious), outcome "unknown", described as "jaw pain".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have rebound covid sicker than the first time; I have rebound covid sicker than the first time; This is a spontaneous report received from a Nurse.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Sep2023 at 08:00 as dose number unknown, single at the age of 63 years, in left 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 "I have rebound covid sicker than the first time". Therapeutic measures were taken which was Paxlovid as a result of drug ineffective, covid-19.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Monday night symptoms and then + test; Monday night symptoms and then + test; This is a spontaneous report received from a Nurse from product quality group.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Lot number: HF9275) at the age of 65 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2024, outcome "unknown" and all described as "Monday night symptoms and then + test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2024) Positive, notes: covid test type post vaccination =Nasal Swab, Covid test name post vaccination=unknown,  Covid test date=23Jan2024, Covid test result=Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Vaccine was administered in clinic.  No follow-up attempts are possible.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Vaccination failure , COVID-19 cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I want to complain about COVID vaccine I had 3 shots and had COVID; I want to complain about COVID vaccine I had 3 shots and had COVID; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I want to complain about COVID vaccine I had 3 shots and had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. It was unknown if 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400023597 same patient/vaccine and different vaccine dose number/event;
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Decreased appetite, Dizziness, Food allergy, Hip arthroplasty
Clinical narrative: dizziness; Yeast allergy; hip replaced; Vomit; loss of appetite; Loss of Equilibrium; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Premature ventricular contractions" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 Immunization. The following information was reported: BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Loss of Equilibrium"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "Vomit"; HIP ARTHROPLASTY (medically significant) with onset Jun2021, outcome "unknown", described as "hip replaced"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "loss of appetite"; FOOD ALLERGY (non-serious) with onset May2022, outcome "unknown", described as "Yeast allergy"; DIZZINESS (non-serious), outcome "unknown".  Patient's clinical course was the following: Caller states since he got the second one on Feb2021, he started with vomit, loss of appetite, loss of equilibrium. Caller wants to know whether these adverse reactions have been reported before or not. Caller states since that moment he developed an allergic reaction to yeast. Caller wants to know recommendations on how to manage this reaction. He knew it was related to the shot and had his hip replaced in Jun2021 and had two more shots after that then discovered the yeast allergy in May2022.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizziness; Yeast allergy; hip replaced; Vomit; loss of appetite; Loss of Equilibrium; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Premature ventricular contractions" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 Immunization. The following information was reported: BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Loss of Equilibrium"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "Vomit"; HIP ARTHROPLASTY (medically significant) with onset Jun2021, outcome "unknown", described as "hip replaced"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "loss of appetite"; FOOD ALLERGY (non-serious) with onset May2022, outcome "unknown", described as "Yeast allergy"; DIZZINESS (non-serious), outcome "unknown".  Patient's clinical course was the following: Caller states since he got the second one on Feb2021, he started with vomit, loss of appetite, loss of equilibrium. Caller wants to know whether these adverse reactions have been reported before or not. Caller states since that moment he developed an allergic reaction to yeast. Caller wants to know recommendations on how to manage this reaction. He knew it was related to the shot and had his hip replaced in Jun2021 and had two more shots after that then discovered the yeast allergy in May2022.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 51.0
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 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (DOSE 1, SINGLE), administration date: 08Mar2021, when the patient was 50-year-old, for COVID-19 Immunization; pfizer / biontech (DOSE 2, SINGLE), administration date: 29Mar2021, when the patient was 50-year-old, for COVID-19 Immunization; pfizer / biontech (DOSE 3 (BOOSTER), SINGLE), administration date: 30Sep2021, for COVID-19 Immunization; pfizer / biontech (DOSE 4 (BOOSTER), SINGLE), administration date: 10May2022, 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2024) Negative, notes: Test negative on two tests for covid on 23Jan2024; (23Jan2024) Negative, notes: Test negative on two tests for covid on 23Jan2024; (24Jan2024) Positive, notes: The following  day, 24Jan2024, I tested positive again on three tests; (24Jan2024) Positive, notes: The following  day, 24Jan2024, I tested positive again on three tests; (24Jan2024) Positive, notes: The following  day, 24Jan2024, I tested positive again on three tests. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 16Jan2024 to 20Jan2024.  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: Balance disorder, Decreased appetite, Dizziness, Vomiting
Clinical narrative: Vomit; loss of appetite; Loss of Equilibrium; lightheadedness; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old male 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 included: "Premature ventricular contractions" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (vaccinated with 5 COVID shots until this day), for COVID-19 immunisation. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomit"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Loss of Equilibrium"; DIZZINESS (non-serious), outcome "unknown", described as "lightheadedness".  Additional information: Patient vomited, had loss of appetite a few days and had severe dizziness and then it got less severe until the dizziness dissipated 9-10 days and those were the most severe symptoms and since then he had vomited one other time that lasted 3-4 days and recently had lightheadedness in November for 4-5 days before that went away and that occurred in Nov2023 and he was dealing with it yesterday. On the 11th and 22nd of November he had for a few days the lightheadedness and did not have any vomiting that time and then just recently again had it again and is saying he is getting it more often and it had petered out so he had not seen too much of it but does not remember until recently again and called and talked to the pharmacy again. He has a new inhaler he is taking and the pharmacy is doing their side of it and they are thinking the inhaler was something to do with it.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Johnson and Johnson/ Dose #2: Pfizer; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 03Apr2021 as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Mixed Connective Tissue Autoimmune disease" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose #1: Johnson and Johnson/ Dose #2: Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2024) Negative, notes: Rebound COVID effect - tested negative 21Jan2024 and testing positive 24Jan2024 with return of symptoms (stuffy nose and tiredness); (24Jan2024) Positive, notes: Rebound COVID effect - tested negative 21Jan2024 and testing positive 24Jan2024 with return of symptoms (stuffy nose and tiredness). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 15Jan2024 to 19Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: but still contracted COVID-19  in Mar2022 and again today 17Jan2024; but still contracted COVID-19 in Mar2022 and again today 17Jan2024; 21Oct2022 (PFIZER GJ6739) and 14Oct2023 (SPIKEVAX); This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): (Merck).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Lot number: GJ6739) for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6200), on 19Mar2021 as dose 2, single (Lot number: EN6203) and on 03Dec2021 as dose 3 (booster), single (Lot number: 33130BA) for covid-19 immunisation; elasomeran (SPIKEVAX), on 14Oct2023 as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Mar2022 (unspecified if ongoing); "does not feel well" (unspecified if ongoing), notes: does not feel well. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Oct2023, outcome "unknown", described as "21Oct2022 (PFIZER GJ6739) and 14Oct2023 (SPIKEVAX)"; DRUG INEFFECTIVE (medically significant) with onset 17Jan2024, outcome "unknown", described as "but still contracted COVID-19  in Mar2022 and again today 17Jan2024"; SUSPECTED COVID-19 (medically significant) with onset 17Jan2024, outcome "unknown", described as "but still contracted COVID-19 in Mar2022 and again today 17Jan2024".  Clinical course: A consumer reported that she had been vaccinated for Covid-19 on 26Feb2021 (Pfizer EN6200), 19Mar2021 (Pfizer EN6203), 03Dec2021 (Pfizer 33130BA), 21Oct2022 (Pfizer GJ6739) and 14Oct2023 (Spikevax 203F2391? or 203F23A1? caller stated it was hard to read), but still contracted COVID-19 in Mar2022 and again on 17Jan2024.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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. Vaccination history included: Pfizer biontech vaccine (Dose 1, single), for COVID-19 Immunization; Pfizer biontech vaccine (Dose 2, single), for COVID-19 Immunization; Pfizer biontech vaccine (Dose 3, single), for COVID-19 Immunization. The following information was reported: COUGH (non-serious), outcome "not recovered".  Additional information:  She has had 4 Pfizer COVID shots and she cannot get rid of a cough that she has. She wanted to know if this may be a side effect of the vaccines.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Aplastic anaemia
Clinical narrative: Aplastic anemia; This is a spontaneous report received from a Consumer or other non HCP.  A 21-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: APLASTIC ANAEMIA (medically significant), outcome "unknown", described as "Aplastic anemia". Therapeutic measures were taken as a result of aplastic anaemia.  Additional information: The reporter sated, "I just wanted to list the side effects from the COVID-19, 'Ethmoid' shot because one of my family member my wife specifically received the 'Ethmoid' shot and then got aplastic anemia from the shot so they have to give her chemo and replace all the blood in her body and she nearly died. I just want to know if that is on the list." When asked about product details, "No, I do not but I do know that the vaccination was one of the very first ones that were tanned out. No, totally not." When asked about vaccination facility, "I am not sure I recall that was many years ago." Reporter stated, "Just the 2 part shot for the mRNA injection, this is the first one and then the second one that they did right here. I would not know quantities." The reporter mentioned that patient only has been doing lab tests for the disease aplastic anemia which was caused by vaccine. Treatment included surgery chemotherapy, steroid usage, drained almost all of her blood and then replace with a donors bone marrow so that she can produce her own blood again.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Liver function test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "70% of her left lung and right lung was completely paralyzed", start date: 2010 (ongoing), notes: left lung since 2010 it is 70%; "disabled" (unspecified if ongoing); "acute bronchial asthma" (unspecified if ongoing); "mild COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: Liver function test: (2010) 70 %, notes: for the left lung since 2010 it is 70 percent. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was calling about the pills for COVID19; states she has used Pfizer before for all the shots and all her medications and stuff and she is disabled. States she feels pretty bad and just wants to get the pills. Her right lung was paralyzed and has acute bronchial asthma and mild COPD and the right lung is paralyzed and for the left lung since 2010 it is 70 percent. States this is hard to do as she is barely breathing and having to fight for breath.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 59.0
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 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "history of pneumonia" (unspecified if ongoing). There were no concomitant medications. 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 (booster); unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (booster); unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive; (Jan2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid started on 08Jan2024 to 13Jan2024.   Clinical course: The patient had no other medication in 2 weeks.   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, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Lot number: HG4659) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "low thyroid" (unspecified if ongoing); "Menopause" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies". Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE, Lot number: gj6665, Anatomical location: Arm Right), administration date: 30Oct2022, when the patient was 54-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, Lot number: 046L21A, Anatomical location: Arm Left), administration date: 10Apr2022, when the patient was 54-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 1, SINGLE, Lot number: 071F21a, Anatomical location: Arm Left), administration date: 19Nov2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, which included nirmatrelvir, ritonavir (PAXLOVID) from 12Jan2024 to 16Jan2024.
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 51-year-old male 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. 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive, notes: Test positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received PAXLOVID from 15Jan2024 to 19Jan2024 for Treatment of COVID-19. Rebound on 24Jan2024. Test positive again. And don't feel that great.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 78.0
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.  An elderly female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE, Location of injection: Arm Right), administration date: 28Apr2023, when the patient was 78-year-old, 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". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took Paxlovid for treatment of Covid from 09Jan2024 to 14Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 22.0
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 23-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures 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.