chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Interchange of vaccine products, Muscular weakness, Off label use
Clinical narrative: sore throat; tiredness in her legs; insomnia; prev_dose_product=COVID 19, prev_dose_brand=Johnson & Johnson, prev_dose_dose number=1/product=COVID 19, brand=Pfizer, dose number=2; prev_dose_product=COVID 19, prev_dose_brand=Johnson & Johnson, prev_dose_dose number=1/product=COVID 19, brand=Pfizer, dose number=2; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson &Johnson (Dose Number: 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 23Nov2021, outcome "unknown" and all described as "prev_dose_product=COVID 19, prev_dose_brand=Johnson & Johnson, prev_dose_dose number=1/product=COVID 19, brand=Pfizer, dose number=2"; IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (non-serious) with onset 24Nov2021, outcome "recovered" (27Nov2021), described as "sore throat"; MUSCULAR WEAKNESS (non-serious) with onset 23Nov2021, outcome "recovered" (27Nov2021), described as "tiredness in her legs"; INSOMNIA (non-serious) with onset 23Nov2021, outcome "recovered" (27Nov2021), described as "insomnia". Therapeutic measures were not taken as a result of oropharyngeal pain, muscular weakness, insomnia.  Additional information: The patient did not experience any fever. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; tiredness in her legs; insomnia; prev_dose_product=COVID 19, prev_dose_brand=Johnson & Johnson, prev_dose_dose number=1/product=COVID 19, brand=Pfizer, dose number=2; prev_dose_product=COVID 19, prev_dose_brand=Johnson & Johnson, prev_dose_dose number=1/product=COVID 19, brand=Pfizer, dose number=2; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson &Johnson (Dose Number: 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 23Nov2021, outcome "unknown" and all described as "prev_dose_product=COVID 19, prev_dose_brand=Johnson & Johnson, prev_dose_dose number=1/product=COVID 19, brand=Pfizer, dose number=2"; IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (non-serious) with onset 24Nov2021, outcome "recovered" (27Nov2021), described as "sore throat"; MUSCULAR WEAKNESS (non-serious) with onset 23Nov2021, outcome "recovered" (27Nov2021), described as "tiredness in her legs"; INSOMNIA (non-serious) with onset 23Nov2021, outcome "recovered" (27Nov2021), described as "insomnia". Therapeutic measures were not taken as a result of oropharyngeal pain, muscular weakness, insomnia.  Additional information: The patient did not experience any fever. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Immunisation, Presyncope, Syncope
Clinical narrative: faint and nearly passed out; faint and nearly passed out; dose number=3; bleeding quite a lot (blood dripping down arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 12:00 (Lot number: FS8757) at the age of 23 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM; VYVANSE; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose product=COVID 19, prev dose brand=Pfizer, Batch/Lot No: EW0168), administration date: 06May2021, when the patient was 23 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product=COVID 19, prev dose brand=Pfizer, Batch/Lot No: ER8731), administration date: 15Apr2021, when the patient was 23 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Nov2021 12:00, outcome "unknown", described as "dose number=3"; HAEMORRHAGE (medically significant) with onset 30Nov2021 12:00, outcome "recovered" (30Nov2021), described as "bleeding quite a lot (blood dripping down arm)"; PRESYNCOPE (medically significant), SYNCOPE (medically significant) all with onset 30Nov2021 12:05, outcome "recovered" (30Nov2021 12:20) and all described as "faint and nearly passed out". Therapeutic measures were not taken as a result of haemorrhage, presyncope, syncope. Clinical course: No known allergies, no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Immediately following the vaccination, I started bleeding quite a lot (blood dripping down arm) and it took a while (1 minute) to stop the bleeding. About 5 minutes later, I became faint and nearly passed out. I recovered in about 15 minutes.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Plague, Pruritus, Rash macular
Clinical narrative: Booster; Itchy plagues; developed spotty areas that itch all over my body, most on the left side, around 10; developed spotty areas that itch all over my body, most on the left side, around 10; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Oct2021 16:00 (Lot number: FE3592) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OZEMPIC taken for weight decreased, start date: Oct2020 (ongoing). Vaccination history included: Bnt162b2 (2nd dose, Time: 5 pm, Anatomical Site of injection: Left upper arm, Route of Administration: Intramuscular, Batch/lot number: EL3248), administration date: 12Jan2021, when the patient was 57 years old, for COVID-19 immunization, reaction(s): "spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months", "spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months"; Bnt162b2 (Dose: 01, Time: 5 Pm, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/lot number: EK9231), administration date: 22Dec2020, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 05Oct2021 16:00, outcome "unknown", described as "Booster"; PLAGUE (medically significant) with onset 2021, outcome "not recovered", described as "Itchy plagues"; RASH MACULAR (non-serious), PRURITUS (non-serious) all with onset 2021, outcome "unknown" and all described as "developed spotty areas that itch all over my body, most on the left side, around 10". Therapeutic measures were taken as a result of plague, rash macular, pruritus included OTC hydrocortisone. relevant tests and specific tests were none. Clinical course as follows: The only reason patient thought it may be related to the vaccine is that after her booster that area became extremely itchy + with almost a plaque. That spot has gone but others are still there largest gone largest area is 2 cm x 2cm. Itchy Plaques was reported as Not Serious.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunisation and Plague, and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101495494 Same patient/Vaccine, different event, different vaccine dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Nervous system disorder, Rheumatoid arthritis, Tremor
Clinical narrative: vitreous detachment; severe arthritis/diagnosed with rheumatoid arthritis; joint pain; dizziness/vertigo; dizziness/vertigo; neurological effects; severe external and internal tremors; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 07May2021 (Lot number: EW0182) at the age of 49 years as dose 2, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/facility. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot number: EW0153, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: VITREOUS DETACHMENT (disability) with onset May2021, outcome "not recovered", described as "vitreous detachment"; RHEUMATOID ARTHRITIS (disability) with onset May2021, outcome "not recovered", described as "severe arthritis/diagnosed with rheumatoid arthritis"; ARTHRALGIA (disability) with onset May2021, outcome "not recovered", described as "joint pain"; DIZZINESS (disability), VERTIGO (disability) all with onset May2021, outcome "not recovered" and all described as "dizziness/vertigo"; NERVOUS SYSTEM DISORDER (disability) with onset May2021, outcome "not recovered", described as "neurological effects"; TREMOR (disability) with onset May2021, outcome "not recovered", described as "severe external and internal tremors". The events "vitreous detachment", "severe arthritis/diagnosed with rheumatoid arthritis", "joint pain", "dizziness/vertigo", "neurological effects" and "severe external and internal tremors" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vitreous detachment, rheumatoid arthritis, arthralgia, dizziness, vertigo, nervous system disorder, tremor: Prednisone, Hydroxychloroquine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vitreous detachment
Clinical narrative: vitreous detachment; severe arthritis/diagnosed with rheumatoid arthritis; joint pain; dizziness/vertigo; dizziness/vertigo; neurological effects; severe external and internal tremors; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 07May2021 (Lot number: EW0182) at the age of 49 years as dose 2, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/facility. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot number: EW0153, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: VITREOUS DETACHMENT (disability) with onset May2021, outcome "not recovered", described as "vitreous detachment"; RHEUMATOID ARTHRITIS (disability) with onset May2021, outcome "not recovered", described as "severe arthritis/diagnosed with rheumatoid arthritis"; ARTHRALGIA (disability) with onset May2021, outcome "not recovered", described as "joint pain"; DIZZINESS (disability), VERTIGO (disability) all with onset May2021, outcome "not recovered" and all described as "dizziness/vertigo"; NERVOUS SYSTEM DISORDER (disability) with onset May2021, outcome "not recovered", described as "neurological effects"; TREMOR (disability) with onset May2021, outcome "not recovered", described as "severe external and internal tremors". The events "vitreous detachment", "severe arthritis/diagnosed with rheumatoid arthritis", "joint pain", "dizziness/vertigo", "neurological effects" and "severe external and internal tremors" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vitreous detachment, rheumatoid arthritis, arthralgia, dizziness, vertigo, nervous system disorder, tremor: Prednisone, Hydroxychloroquine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure, Myocardial infarction
Clinical narrative: Heart Failure; AFIB; Death by probable Myocardial Infarction; This is a spontaneous report received from a contactable Consumer.  An 85 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 26Feb2021 13:00 (Lot number: EN6201) at the age of 85 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). There were no known allergies. The patient took unspecified concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EL9262, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 20Jan2021, when the patient was 85 years old, for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: MYOCARDIAL INFARCTION (death) with onset 22Sep2021, outcome "fatal", described as "Death by probable Myocardial Infarction"; ATRIAL FIBRILLATION (hospitalization, life threatening) with onset 12May2021, outcome "unknown", described as "AFIB"; CARDIAC FAILURE (hospitalization, life threatening) with onset 01Jul2021, outcome "unknown", described as "Heart Failure". The patient was hospitalized for atrial fibrillation, cardiac failure (start date: 2021, discharge date: 2021, hospitalization duration: 5 days). The events "death by probable myocardial infarction", "afib" and "heart failure" were evaluated at the physician office visit and emergency room visit. A pacemaker placed on 02Jul2021 upon heart failure. Therapeutic measures were taken as a result of atrial fibrillation, cardiac failure. The patient date of death was 22Sep2021. The reported cause of death was myocardial infarction. No autopsy was performed.  Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Probable Myocardial Infarction
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium, Blood sodium decreased, Body temperature, Constipation, Dehydration
Clinical narrative: Booster dose; Got a temperature of a 103; It caused me not to go to the bathroom and I just did not/ I wasn't peeing; My sodium had gone much too low; I was dehydrated/ High temperature was using up all the liquid in my body; I suddenly gained 10 pounds; Constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Lot number: 32030BD) at the age of 83 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing), notes: not taking any medication for that; "heart condition" (unspecified if ongoing), notes: have a heart condition and is taking 'Norpace'. Concomitant medication(s) included: NORPACE taken for cardiac disorder. Vaccination history included: Covid-19 vaccine (Dose:01, Unknown manufacturer, unknown lot number), for Covid-19 immunization; Covid-19 vaccine (Dose:02, Unknown manufacturer, unknown lot number), for Covid-19 immunization. No any prior vaccinations. The following information was reported: PYREXIA (hospitalization) with onset 2021, outcome "unknown", described as "Got a temperature of a 103"; URINE OUTPUT DECREASED (hospitalization) with onset 2021, outcome "unknown", described as "It caused me not to go to the bathroom and I just did not/ I wasn't peeing"; BLOOD SODIUM DECREASED with onset 2021, outcome "unknown", described as "My sodium had gone much too low"; DEHYDRATION with onset 2021, outcome "unknown", described as "I was dehydrated/ High temperature was using up all the liquid in my body"; WEIGHT INCREASED with onset 2021, outcome "unknown", described as "I suddenly gained 10 pounds"; CONSTIPATION with onset 2021, outcome "unknown", described as "Constipation". The patient was hospitalized for pyrexia, urine output decreased (start date: 17Nov2021, discharge date: 18Nov2021, hospitalization duration: 1 day(s)). The events "got a temperature of a 103" and "it caused me not to go to the bathroom and I just did not/ I wasn't peeing" were evaluated at the emergency room visit. Additional infomation: Consumer stated that she had an adverse reaction to the Pfizer booster shot and they sent her to the hospital twice and she wants to report it.". Vaccine name: Pfizer Covid-19 Vaccine. Weight: Consumer stated, her weight is 94 or 95 pounds. When further confirmed if discharged date is 18Nov2021, consumer stated that she think so. Treatment: Consumer stated, "The first time, they gave me, I was dehydrated, the high temperature was using up all the liquid in my body and so, they told me to take Tylenol. The patient underwent the following laboratory tests and procedures: blood sodium: (2021) too low, notes: sodium had gone much too low; body temperature: (2021) 103, notes: high; investigation: (2021) unknown results; weight increased: (2021) 10, notes: pounds. Therapeutic measures were taken as a result of pyrexia, treatment included Tylenol.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Investigation, Pyrexia, Urine output decreased, Weight increased
Clinical narrative: Booster dose; Got a temperature of a 103; It caused me not to go to the bathroom and I just did not/ I wasn't peeing; My sodium had gone much too low; I was dehydrated/ High temperature was using up all the liquid in my body; I suddenly gained 10 pounds; Constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Lot number: 32030BD) at the age of 83 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing), notes: not taking any medication for that; "heart condition" (unspecified if ongoing), notes: have a heart condition and is taking 'Norpace'. Concomitant medication(s) included: NORPACE taken for cardiac disorder. Vaccination history included: Covid-19 vaccine (Dose:01, Unknown manufacturer, unknown lot number), for Covid-19 immunization; Covid-19 vaccine (Dose:02, Unknown manufacturer, unknown lot number), for Covid-19 immunization. No any prior vaccinations. The following information was reported: PYREXIA (hospitalization) with onset 2021, outcome "unknown", described as "Got a temperature of a 103"; URINE OUTPUT DECREASED (hospitalization) with onset 2021, outcome "unknown", described as "It caused me not to go to the bathroom and I just did not/ I wasn't peeing"; BLOOD SODIUM DECREASED with onset 2021, outcome "unknown", described as "My sodium had gone much too low"; DEHYDRATION with onset 2021, outcome "unknown", described as "I was dehydrated/ High temperature was using up all the liquid in my body"; WEIGHT INCREASED with onset 2021, outcome "unknown", described as "I suddenly gained 10 pounds"; CONSTIPATION with onset 2021, outcome "unknown", described as "Constipation". The patient was hospitalized for pyrexia, urine output decreased (start date: 17Nov2021, discharge date: 18Nov2021, hospitalization duration: 1 day(s)). The events "got a temperature of a 103" and "it caused me not to go to the bathroom and I just did not/ I wasn't peeing" were evaluated at the emergency room visit. Additional infomation: Consumer stated that she had an adverse reaction to the Pfizer booster shot and they sent her to the hospital twice and she wants to report it.". Vaccine name: Pfizer Covid-19 Vaccine. Weight: Consumer stated, her weight is 94 or 95 pounds. When further confirmed if discharged date is 18Nov2021, consumer stated that she think so. Treatment: Consumer stated, "The first time, they gave me, I was dehydrated, the high temperature was using up all the liquid in my body and so, they told me to take Tylenol. The patient underwent the following laboratory tests and procedures: blood sodium: (2021) too low, notes: sodium had gone much too low; body temperature: (2021) 103, notes: high; investigation: (2021) unknown results; weight increased: (2021) 10, notes: pounds. Therapeutic measures were taken as a result of pyrexia, treatment included Tylenol.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 despite being vaccinated; tested positive for COVID-19 despite being vaccinated; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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 "recovering" and all described as "tested positive for COVID-19 despite being vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tested positive for COVID-19 despite being vaccinated. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Rash, SARS-CoV-2 test
Clinical narrative: he tested positive for COVID-19 on 20Nov2021 after being exposed to another person; rash on his head, arms, back at the top of his feet and a little on his left nipple; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 13Nov2021 (Batch/Lot number: unknown) as dose 1, (tris) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 20Nov2021, outcome "unknown", described as "he tested positive for COVID-19 on 20Nov2021 after being exposed to another person"; RASH (non-serious) with onset Nov2021, outcome "unknown", described as "rash on his head, arms, back at the top of his feet and a little on his left nipple". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: For the body rash they gave him some antihistamine and lotion which kept it from spreading. The patient is scheduled to receive his second dose of Pfizer Covid Shot For Children Between 5 and 11 on 04Dec2021.  Description of Product Complaint: Consumer called regarding patient who was reporter child. The patient was administered first dose of Pfizer covid Shot for children between 5 and 11 on 13Nov2021. They received an email that the patient had been in contact with a someone who tested positive for Covid. On 20Nov2021 the patient had a fever and was tested for COVID on 20Nov2021, 21Nov2021 and several other times and COVID test was positive for COVID-unable to clarify which COVID test or tests were positive or if all were positive.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Your Covid 19 vaccine (described as flu shot) killed my friend (patient); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Your Covid 19 vaccine (described as flu shot) killed my friend (patient) ". The patient date of death was unknown. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Your Covid 19 vaccine (described as flu shot) killed my friend (patient)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I had Covid at the end of Sep of this year, 2021; I had Covid at the end of Sep of this year, 2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2021 13:00 (Lot number: EK9231) at the age of 38 years as dose 2, single and administered in arm right, administration date 18Dec2020 13:00 (Lot number: ELO140) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant) with onset Sep2021, outcome "recovered", COVID-19 (medically significant) with onset Sep2021, outcome "recovered" (2021) and all described as "I had Covid at the end of Sep of this year, 2021".  Clinical information: My husband and I had Covid at the end of Sep of this year, 2021. We recovered and our taste and smell were completely back to normal for many weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Known allergies. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Delirium, Illness, Pyrexia, Tremor
Clinical narrative: Delirious; Violently sick; High fever; Shakes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation in "Other" facility type. The patient's relevant medical history was not reported. There was no known allergies. There were no concomitant medications. The patient did not receive other medications within two weeks and not receive other vaccine within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown as unable to locate or read the details, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 38 years old, for COVID-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested COVID-19 post vaccination. The following information was reported: DELIRIUM (medically significant) with onset 2021, outcome "recovered" (2021), described as "Delirious"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Violently sick"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "High fever"; TREMOR (non-serious) with onset 2021, outcome "recovered" (2021), described as "Shakes". The patient underwent the following laboratory tests and procedures: body temperature: (2021) high.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I have a breakthrough COVID; I have a breakthrough COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2021 (Lot number: EL3247) at the age of 32 years as dose 2, single and intramuscular, administered in arm left, administration date 08Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Nov2021, outcome "recovering" and all described as "I have a breakthrough COVID". The event "i have a breakthrough covid" and "i have a breakthrough covid" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Nov2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient did not had covid prior vaccination and any known allergies. The patient did not receive other vaccine in four weeks.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Feeling abnormal, Oropharyngeal pain
Clinical narrative: received a positive result / covid test result = Positive; received a positive result / covid test result = Positive; the patient began "feeling off"; mild body aches; 100 degree fever; slight cough; minor sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 25 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jan2021 (Lot number: EK9262) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231), administration date: 06Jan2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Dec2021, outcome "not recovered" and all described as "received a positive result / covid test result = Positive"; FEELING ABNORMAL (non-serious) with onset 30Nov2021, outcome "not recovered", described as "the patient began "feeling off""; PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "mild body aches"; PYREXIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "100 degree fever"; COUGH (non-serious) with onset 30Nov2021, outcome "not recovered", described as "slight cough"; OROPHARYNGEAL PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "minor sore throat". The patient underwent the following laboratory tests and procedures: body temperature: (30Nov2021) 100 degrees, notes: fever; sars-cov-2 test: (01Dec2021) positive, notes: The patient submitted to a PCR test on the morning of 01Dec2021 and received a positive result later that day. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, feeling abnormal, pain, pyrexia, cough, oropharyngeal pain. The patient is a healthy (Age Withheld) y/o male working as a physician assistant, who received two doses of Pfizer COVID vaccine in Jan2021. After attending a 250-person indoor wedding reception on 27Nov021 (at which there was at least one attendee who tested positive for COVID-19 within 48 hours after the event), the patient began AE on 11/30/2021. Patient reports only mild symptoms thus far and was scheduled to receive his booster on 03Dec2021.Covid prior vaccination was reported as no and covid tested post vaccination was reported as yes. It was unknown whether patient received any other vaccine in four weeks. Ae resulted in: None of the above.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: received a positive result / covid test result = Positive; received a positive result / covid test result = Positive; the patient began "feeling off"; mild body aches; 100 degree fever; slight cough; minor sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 25 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jan2021 (Lot number: EK9262) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231), administration date: 06Jan2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Dec2021, outcome "not recovered" and all described as "received a positive result / covid test result = Positive"; FEELING ABNORMAL (non-serious) with onset 30Nov2021, outcome "not recovered", described as "the patient began "feeling off""; PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "mild body aches"; PYREXIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "100 degree fever"; COUGH (non-serious) with onset 30Nov2021, outcome "not recovered", described as "slight cough"; OROPHARYNGEAL PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "minor sore throat". The patient underwent the following laboratory tests and procedures: body temperature: (30Nov2021) 100 degrees, notes: fever; sars-cov-2 test: (01Dec2021) positive, notes: The patient submitted to a PCR test on the morning of 01Dec2021 and received a positive result later that day. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, feeling abnormal, pain, pyrexia, cough, oropharyngeal pain. The patient is a healthy (Age Withheld) y/o male working as a physician assistant, who received two doses of Pfizer COVID vaccine in Jan2021. After attending a 250-person indoor wedding reception on 27Nov021 (at which there was at least one attendee who tested positive for COVID-19 within 48 hours after the event), the patient began AE on 11/30/2021. Patient reports only mild symptoms thus far and was scheduled to receive his booster on 03Dec2021.Covid prior vaccination was reported as no and covid tested post vaccination was reported as yes. It was unknown whether patient received any other vaccine in four weeks. Ae resulted in: None of the above.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Delirium, Immunisation, Pyrexia
Clinical narrative: Booster; delirious; high fever; shakes; massive joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 09:30 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient did not receive any other medications within two weeks and not receive any other vaccine within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1 Batch/Lot No: Unknown. Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2 Batch/Lot No: Unknown.), administration date: 26Apr2021, when the patient was 38 years old, for COVID-19 Immunization, reaction(s): violently sick with high fever, shakes, and delirious. lasted several days. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021 09:30, outcome "unknown", described as "Booster"; DELIRIUM (medically significant) with onset Dec2021, outcome "unknown", described as "delirious"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "high fever"; TREMOR (non-serious) with onset Dec2021, outcome "unknown", described as "shakes"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "massive joint pain". The patient underwent the following laboratory tests and procedures: body temperature: (2021) high, notes: After 2nd vaccine; (Dec2021) high. The events were reported as non-serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Booster; delirious; high fever; shakes; massive joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 09:30 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient did not receive any other medications within two weeks and not receive any other vaccine within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1 Batch/Lot No: Unknown. Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2 Batch/Lot No: Unknown.), administration date: 26Apr2021, when the patient was 38 years old, for COVID-19 Immunization, reaction(s): violently sick with high fever, shakes, and delirious. lasted several days. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021 09:30, outcome "unknown", described as "Booster"; DELIRIUM (medically significant) with onset Dec2021, outcome "unknown", described as "delirious"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "high fever"; TREMOR (non-serious) with onset Dec2021, outcome "unknown", described as "shakes"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "massive joint pain". The patient underwent the following laboratory tests and procedures: body temperature: (2021) high, notes: After 2nd vaccine; (Dec2021) high. The events were reported as non-serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swollen face in side of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 05Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization. The following information was reported: SWELLING FACE (medically significant) with onset 05Dec2021, outcome "recovered", described as "Swollen face in side of injection". The event "swollen face in side of injection" was evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling face. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was Bendryl. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Brain injury, Coma, Myocardial infarction
Clinical narrative: Had a heart attack; left them with significant brain damage; They went into a coma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant) with onset 2021, outcome "fatal", described as "Had a heart attack"; BRAIN INJURY (medically significant) with onset 2021, outcome "unknown", described as "left them with significant brain damage"; COMA (medically significant) with onset 2021, outcome "unknown", described as "They went into a coma". The patient date of death was unknown. The reported cause of death was myocardial infarction. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart attack that left them with significant brain damage
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dandruff, Joint swelling, Musculoskeletal discomfort, Myocarditis
Clinical narrative: Has some sort of skin condition on scalp that may need to be treated - visually causes dandruff".; myocarditis; swollen ankles; Potential heart Palpitations; body falling apart; back issues; Has some sort of skin condition on scalp that may need to be treated - visually causes dandruff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 30's received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "history drug/alcohol abuse" (unspecified if ongoing), notes: history drug/alcohol abuse; "history drug/alcohol abuse" (unspecified if ongoing), notes: history drug/alcohol abuse; "HPV" (unspecified if ongoing), notes: previous report, unconfirmed but mentioned HPV. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; JOINT SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swollen ankles"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "Potential heart Palpitations"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "body falling apart"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "back issues"; DANDRUFF (non-serious) with onset 2021, outcome "unknown", described as "Has some sort of skin condition on scalp that may need to be treated - visually causes dandruff"; SKIN DISORDER (non-serious), outcome "unknown", described as "Has some sort of skin condition on scalp that may need to be treated - visually causes dandruff".". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Skin disorder
Clinical narrative: Has some sort of skin condition on scalp that may need to be treated - visually causes dandruff".; myocarditis; swollen ankles; Potential heart Palpitations; body falling apart; back issues; Has some sort of skin condition on scalp that may need to be treated - visually causes dandruff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 30's received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "history drug/alcohol abuse" (unspecified if ongoing), notes: history drug/alcohol abuse; "history drug/alcohol abuse" (unspecified if ongoing), notes: history drug/alcohol abuse; "HPV" (unspecified if ongoing), notes: previous report, unconfirmed but mentioned HPV. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; JOINT SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swollen ankles"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "Potential heart Palpitations"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "body falling apart"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "back issues"; DANDRUFF (non-serious) with onset 2021, outcome "unknown", described as "Has some sort of skin condition on scalp that may need to be treated - visually causes dandruff"; SKIN DISORDER (non-serious), outcome "unknown", described as "Has some sort of skin condition on scalp that may need to be treated - visually causes dandruff".". The lot number for bnt162b2 was not provided and will be requested during follow up.