chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Incorrect product formulation administered, Insomnia, Pain
Clinical narrative: the next day she was running a little fever for a couple of hours and the fever came back with the temperature of 100°C; pain in the arm; couldn't sleep the first night after receiving the 2nd shot; the facility mistakenly administered saline from the vials; She mentioned that she feels achy and tired; She mentioned that she feels achy and tired; This is a spontaneous report from a contactable consumer or other non hcp (patient herself) from a Pfizer Sponsored Program Support. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 31Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. It was reported she experienced the normal reaction after receiving the 2nd shot; pain in the arm, couldn't sleep the first night after receiving the 2nd shot on 31Mar2021, the next day she was running a little fever for a couple of hours and the fever came back with the temperature of 100 degrees centigrade on 01Apr2021. On an unspecified date in 2021 she mentioned that she feels achy and tired. She stated she received a phone call yesterday from the facility where she received the vaccine stating that they need to be revaccinated. The facility informed her that 10 out of the 100 people who took the 2nd shot, the facility mistakenly administered saline from the vials on 13Apr2021. Stated that the 10 people got the saline vial which they need to do it again for the people who took the covid vaccine. Concerned if she should get the 3rd shot on 31Apr. because she had a normal reaction (side effects) and she might have a severe reaction if she would be revaccinated. Seriousness of the events was non serious. The patient underwent lab tests and procedures which included temperature (body temperature): 100 degrees centigrade on 01Apr2021. The outcome of all the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: the next day she was running a little fever for a couple of hours and the fever came back with the temperature of 100°C; pain in the arm; couldn't sleep the first night after receiving the 2nd shot; the facility mistakenly administered saline from the vials; She mentioned that she feels achy and tired; She mentioned that she feels achy and tired; This is a spontaneous report from a contactable consumer or other non hcp (patient herself) from a Pfizer Sponsored Program Support. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 31Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. It was reported she experienced the normal reaction after receiving the 2nd shot; pain in the arm, couldn't sleep the first night after receiving the 2nd shot on 31Mar2021, the next day she was running a little fever for a couple of hours and the fever came back with the temperature of 100 degrees centigrade on 01Apr2021. On an unspecified date in 2021 she mentioned that she feels achy and tired. She stated she received a phone call yesterday from the facility where she received the vaccine stating that they need to be revaccinated. The facility informed her that 10 out of the 100 people who took the 2nd shot, the facility mistakenly administered saline from the vials on 13Apr2021. Stated that the 10 people got the saline vial which they need to do it again for the people who took the covid vaccine. Concerned if she should get the 3rd shot on 31Apr. because she had a normal reaction (side effects) and she might have a severe reaction if she would be revaccinated. Seriousness of the events was non serious. The patient underwent lab tests and procedures which included temperature (body temperature): 100 degrees centigrade on 01Apr2021. The outcome of all the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pyrexia, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient's husband) reporting for his wife. A 51-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6201; expiration date: Jun 2021), at the age of 51, via an unspecified route of administration, in right arm, on May 7, 2021, at 10:05, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0153; expiration date: Jun 2021), at the age of 51, via an unspecified route of administration, in right arm, on Apr 16, 2021, single dose, for COVID-19 immunisation. On May 7, 2021, patient had a fever, sore arm and bad headache (started a couple of hours after second dose). She took the day off so she could rest. On May 8, 2021 (Saturday), she still had fever, bad headache and pain in arm. On May 9, 2021 (Sunday), she felt a little better. The patient was told by the pharmacy to try and take Tylenol. Fever, sore arm and bad headache ended May 8, 2021 (Saturday). The patient did not have any fever or anything now. On May 10, 2021 (this morning), she was very dizzy and she fell getting out of bed in the morning. She felt dizzy that day. She clarified vaccine as Pfizer BioNTech COVID-19 vaccine. The only thing was dizziness happening now. Dizziness started at 09:00, on May 10, 2021 (today). She stopped taking her medications 3 months prior to getting the vaccine. The outcome of fever, sore arm and bad headache recovered on May 8, 2021; dizziness not recovered and fell getting out of bed: unknown. No follow-up attempts needed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Headache, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient's husband) reporting for his wife. A 51-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6201; expiration date: Jun 2021), at the age of 51, via an unspecified route of administration, in right arm, on May 7, 2021, at 10:05, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0153; expiration date: Jun 2021), at the age of 51, via an unspecified route of administration, in right arm, on Apr 16, 2021, single dose, for COVID-19 immunisation. On May 7, 2021, patient had a fever, sore arm and bad headache (started a couple of hours after second dose). She took the day off so she could rest. On May 8, 2021 (Saturday), she still had fever, bad headache and pain in arm. On May 9, 2021 (Sunday), she felt a little better. The patient was told by the pharmacy to try and take Tylenol. Fever, sore arm and bad headache ended May 8, 2021 (Saturday). The patient did not have any fever or anything now. On May 10, 2021 (this morning), she was very dizzy and she fell getting out of bed in the morning. She felt dizzy that day. She clarified vaccine as Pfizer BioNTech COVID-19 vaccine. The only thing was dizziness happening now. Dizziness started at 09:00, on May 10, 2021 (today). She stopped taking her medications 3 months prior to getting the vaccine. The outcome of fever, sore arm and bad headache recovered on May 8, 2021; dizziness not recovered and fell getting out of bed: unknown. No follow-up attempts needed. No further information expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody increased, Biopsy skin, Blood thyroid stimulating hormone normal, C-reactive protein normal
Clinical narrative: immune mediated small fiber neuropathy; numbness and tingling in one toe on my left foot; numbness and tingling in one toe on my left foot/ paresthesias spread to both feet and both hands in a stocking/glove distribution.; became intermittently painful in nature; This condition has been steadily progressive; This is a spontaneous report from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 at 59-year-old, via an unspecified route of administration in arm right on 08Jan2021 08:00 (Batch/Lot Number: EL3246) at singe dose for COVID-19 immunisation. Medical history included GERD (gastrooesophageal reflux disease), HTN (hypertension), hyerlipidemia, and known allergies: Possible allergy to Thai peppers. No COVID prior vaccination. Concomitant medications were unspecified medications in two weeks. Patient did not receive other vaccine in four weeks. Patient previously received the first dose of BNT162B2 at 59-year-old in right arm on 18Dec2021 (lot number: EK5730) for COVID-19 immunisation. Approximately three weeks after the second vaccine dose, patient began experiencing numbness and tingling in one toe on his left foot. Over the next three months, these paresthesias spreaded to both feet and both hands in a stocking/glove distribution and became intermittently painful in nature. Extensive workup under the direction of neurology and rheumatology specialists included MRIs, EMGs, NCV testing, and lab work. The specialists determined the cause to be an immune mediated small fiber neuropathy. This condition had been steadily progressive and unresponsive to steroids. However, monthly IVIG infusions begun in Jun2021 appear to have slowed the progression of symptoms. Adverse event start date was in Jan2021. AEs resulted in: Doctor or other healthcare professional office/clinic visit. COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Abbott; COVID test date: 07Oct2021; COVID test result: Negative. Outcome of the events was resolving.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Full blood count normal, Glycosylated haemoglobin, Immunoglobulin therapy, Magnetic resonance imaging
Clinical narrative: immune mediated small fiber neuropathy; numbness and tingling in one toe on my left foot; numbness and tingling in one toe on my left foot/ paresthesias spread to both feet and both hands in a stocking/glove distribution.; became intermittently painful in nature; This condition has been steadily progressive; This is a spontaneous report from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 at 59-year-old, via an unspecified route of administration in arm right on 08Jan2021 08:00 (Batch/Lot Number: EL3246) at singe dose for COVID-19 immunisation. Medical history included GERD (gastrooesophageal reflux disease), HTN (hypertension), hyerlipidemia, and known allergies: Possible allergy to Thai peppers. No COVID prior vaccination. Concomitant medications were unspecified medications in two weeks. Patient did not receive other vaccine in four weeks. Patient previously received the first dose of BNT162B2 at 59-year-old in right arm on 18Dec2021 (lot number: EK5730) for COVID-19 immunisation. Approximately three weeks after the second vaccine dose, patient began experiencing numbness and tingling in one toe on his left foot. Over the next three months, these paresthesias spreaded to both feet and both hands in a stocking/glove distribution and became intermittently painful in nature. Extensive workup under the direction of neurology and rheumatology specialists included MRIs, EMGs, NCV testing, and lab work. The specialists determined the cause to be an immune mediated small fiber neuropathy. This condition had been steadily progressive and unresponsive to steroids. However, monthly IVIG infusions begun in Jun2021 appear to have slowed the progression of symptoms. Adverse event start date was in Jan2021. AEs resulted in: Doctor or other healthcare professional office/clinic visit. COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Abbott; COVID test date: 07Oct2021; COVID test result: Negative. Outcome of the events was resolving.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Paraesthesia, Red blood cell sedimentation rate normal, Respiratory viral panel, Small fibre neuropathy
Clinical narrative: immune mediated small fiber neuropathy; numbness and tingling in one toe on my left foot; numbness and tingling in one toe on my left foot/ paresthesias spread to both feet and both hands in a stocking/glove distribution.; became intermittently painful in nature; This condition has been steadily progressive; This is a spontaneous report from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 at 59-year-old, via an unspecified route of administration in arm right on 08Jan2021 08:00 (Batch/Lot Number: EL3246) at singe dose for COVID-19 immunisation. Medical history included GERD (gastrooesophageal reflux disease), HTN (hypertension), hyerlipidemia, and known allergies: Possible allergy to Thai peppers. No COVID prior vaccination. Concomitant medications were unspecified medications in two weeks. Patient did not receive other vaccine in four weeks. Patient previously received the first dose of BNT162B2 at 59-year-old in right arm on 18Dec2021 (lot number: EK5730) for COVID-19 immunisation. Approximately three weeks after the second vaccine dose, patient began experiencing numbness and tingling in one toe on his left foot. Over the next three months, these paresthesias spreaded to both feet and both hands in a stocking/glove distribution and became intermittently painful in nature. Extensive workup under the direction of neurology and rheumatology specialists included MRIs, EMGs, NCV testing, and lab work. The specialists determined the cause to be an immune mediated small fiber neuropathy. This condition had been steadily progressive and unresponsive to steroids. However, monthly IVIG infusions begun in Jun2021 appear to have slowed the progression of symptoms. Adverse event start date was in Jan2021. AEs resulted in: Doctor or other healthcare professional office/clinic visit. COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Abbott; COVID test date: 07Oct2021; COVID test result: Negative. Outcome of the events was resolving.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: immune mediated small fiber neuropathy; numbness and tingling in one toe on my left foot; numbness and tingling in one toe on my left foot/ paresthesias spread to both feet and both hands in a stocking/glove distribution.; became intermittently painful in nature; This condition has been steadily progressive; This is a spontaneous report from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 at 59-year-old, via an unspecified route of administration in arm right on 08Jan2021 08:00 (Batch/Lot Number: EL3246) at singe dose for COVID-19 immunisation. Medical history included GERD (gastrooesophageal reflux disease), HTN (hypertension), hyerlipidemia, and known allergies: Possible allergy to Thai peppers. No COVID prior vaccination. Concomitant medications were unspecified medications in two weeks. Patient did not receive other vaccine in four weeks. Patient previously received the first dose of BNT162B2 at 59-year-old in right arm on 18Dec2021 (lot number: EK5730) for COVID-19 immunisation. Approximately three weeks after the second vaccine dose, patient began experiencing numbness and tingling in one toe on his left foot. Over the next three months, these paresthesias spreaded to both feet and both hands in a stocking/glove distribution and became intermittently painful in nature. Extensive workup under the direction of neurology and rheumatology specialists included MRIs, EMGs, NCV testing, and lab work. The specialists determined the cause to be an immune mediated small fiber neuropathy. This condition had been steadily progressive and unresponsive to steroids. However, monthly IVIG infusions begun in Jun2021 appear to have slowed the progression of symptoms. Adverse event start date was in Jan2021. AEs resulted in: Doctor or other healthcare professional office/clinic visit. COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Abbott; COVID test date: 07Oct2021; COVID test result: Negative. Outcome of the events was resolving.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Electromyogram, Hypoaesthesia, Laboratory test, Magnetic resonance imaging
Clinical narrative: immune mediated small fiber neuropathy; numbness and tingling in one toe on my left foot; numbness and tingling in one toe on my left foot/ paresthesias spread to both feet and both hands in a stocking/glove distribution.; became intermittently painful in nature; This condition has been steadily progressive; This is a spontaneous report from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 at 59-year-old, via an unspecified route of administration in arm right on 08Jan2021 08:00 (Batch/Lot Number: EL3246) at singe dose for COVID-19 immunisation. Medical history included GERD (gastrooesophageal reflux disease), HTN (hypertension), hyerlipidemia, and known allergies: Possible allergy to Thai peppers. No COVID prior vaccination. Concomitant medications were unspecified medications in two weeks. Patient did not receive other vaccine in four weeks. Patient previously received the first dose of BNT162B2 at 59-year-old in right arm on 18Dec2021 (lot number: EK5730) for COVID-19 immunisation. Approximately three weeks after the second vaccine dose, patient began experiencing numbness and tingling in one toe on his left foot. Over the next three months, these paresthesias spreaded to both feet and both hands in a stocking/glove distribution and became intermittently painful in nature. Extensive workup under the direction of neurology and rheumatology specialists included MRIs, EMGs, NCV testing, and lab work. The specialists determined the cause to be an immune mediated small fiber neuropathy. This condition had been steadily progressive and unresponsive to steroids. However, monthly IVIG infusions begun in Jun2021 appear to have slowed the progression of symptoms. Adverse event start date was in Jan2021. AEs resulted in: Doctor or other healthcare professional office/clinic visit. COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Abbott; COVID test date: 07Oct2021; COVID test result: Negative. Outcome of the events was resolving.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nerve conduction studies, Pain, Paraesthesia, SARS-CoV-2 test, Small fibre neuropathy
Clinical narrative: immune mediated small fiber neuropathy; numbness and tingling in one toe on my left foot; numbness and tingling in one toe on my left foot/ paresthesias spread to both feet and both hands in a stocking/glove distribution.; became intermittently painful in nature; This condition has been steadily progressive; This is a spontaneous report from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 at 59-year-old, via an unspecified route of administration in arm right on 08Jan2021 08:00 (Batch/Lot Number: EL3246) at singe dose for COVID-19 immunisation. Medical history included GERD (gastrooesophageal reflux disease), HTN (hypertension), hyerlipidemia, and known allergies: Possible allergy to Thai peppers. No COVID prior vaccination. Concomitant medications were unspecified medications in two weeks. Patient did not receive other vaccine in four weeks. Patient previously received the first dose of BNT162B2 at 59-year-old in right arm on 18Dec2021 (lot number: EK5730) for COVID-19 immunisation. Approximately three weeks after the second vaccine dose, patient began experiencing numbness and tingling in one toe on his left foot. Over the next three months, these paresthesias spreaded to both feet and both hands in a stocking/glove distribution and became intermittently painful in nature. Extensive workup under the direction of neurology and rheumatology specialists included MRIs, EMGs, NCV testing, and lab work. The specialists determined the cause to be an immune mediated small fiber neuropathy. This condition had been steadily progressive and unresponsive to steroids. However, monthly IVIG infusions begun in Jun2021 appear to have slowed the progression of symptoms. Adverse event start date was in Jan2021. AEs resulted in: Doctor or other healthcare professional office/clinic visit. COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Abbott; COVID test date: 07Oct2021; COVID test result: Negative. Outcome of the events was resolving.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Vaginal haemorrhage, Ventricular extrasystoles
Clinical narrative: Heavy periods, heart palpitations, UTI symptoms, Patient has an extreme urge to go to the bathroom but nothing really comes out. It felt like my bladder was full and I had a burning sensation. My son had the same symptom mimicking a uti. After telling my siblings of this, they informed me that they too had that symptom(uti mimicking) I went to the dr about it as did my sister. Both tests came back okay. This should be connected to the vaccines. A total of 4 people in my family gave experiences the uti mimicking symptoms.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac flutter, Electrocardiogram ambulatory, Palpitations, Ventricular extrasystoles
Clinical narrative: Heavy periods, heart palpitations, UTI symptoms, Patient has an extreme urge to go to the bathroom but nothing really comes out. It felt like my bladder was full and I had a burning sensation. My son had the same symptom mimicking a uti. After telling my siblings of this, they informed me that they too had that symptom(uti mimicking) I went to the dr about it as did my sister. Both tests came back okay. This should be connected to the vaccines. A total of 4 people in my family gave experiences the uti mimicking symptoms.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysuria, Electrocardiogram ambulatory abnormal, Heavy menstrual bleeding, Micturition urgency, Palpitations
Clinical narrative: Heavy periods, heart palpitations, UTI symptoms, Patient has an extreme urge to go to the bathroom but nothing really comes out. It felt like my bladder was full and I had a burning sensation. My son had the same symptom mimicking a uti. After telling my siblings of this, they informed me that they too had that symptom(uti mimicking) I went to the dr about it as did my sister. Both tests came back okay. This should be connected to the vaccines. A total of 4 people in my family gave experiences the uti mimicking symptoms.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis normal
Clinical narrative: Heavy periods, heart palpitations, UTI symptoms, Patient has an extreme urge to go to the bathroom but nothing really comes out. It felt like my bladder was full and I had a burning sensation. My son had the same symptom mimicking a uti. After telling my siblings of this, they informed me that they too had that symptom(uti mimicking) I went to the dr about it as did my sister. Both tests came back okay. This should be connected to the vaccines. A total of 4 people in my family gave experiences the uti mimicking symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy breast, Breast cancer stage II, Laboratory test, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: she got another lump with the 2nd vaccine; she had stage 2 metastatic breast cancer.; she has thrush; a throat infection; This is a spontaneous report received from a contactable consumer(patient).   A 36-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0179) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8736) on an unspecified date in May2021 and experienced lymphadenopathy. The patient informed that she got the vaccine in May2021 and her primary wouldn't get her an ultrasound or anything at all saying it was the CDC guidelines to wait for 3 months. Patient experienced a swollen lymph node right away with the 1st dose that was not going away and she got another lump with the 2nd vaccine. Patient underwent an ultrasound in Aug2021 that showed stage 2 metastatic breast cancer. Patient also has a thrush and a throat infection right now and it's hard to talk. The patient had not yet recovered from she got another lump with the 2nd vaccine' and breast cancer stage II, while outcome of other reported events was unknown.   Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101036330 same patient, different vaccine dose/events.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mammogram, Positron emission tomogram, Ultrasound scan
Clinical narrative: she got another lump with the 2nd vaccine; she had stage 2 metastatic breast cancer.; she has thrush; a throat infection; This is a spontaneous report received from a contactable consumer(patient).   A 36-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0179) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8736) on an unspecified date in May2021 and experienced lymphadenopathy. The patient informed that she got the vaccine in May2021 and her primary wouldn't get her an ultrasound or anything at all saying it was the CDC guidelines to wait for 3 months. Patient experienced a swollen lymph node right away with the 1st dose that was not going away and she got another lump with the 2nd vaccine. Patient underwent an ultrasound in Aug2021 that showed stage 2 metastatic breast cancer. Patient also has a thrush and a throat infection right now and it's hard to talk. The patient had not yet recovered from she got another lump with the 2nd vaccine' and breast cancer stage II, while outcome of other reported events was unknown.   Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101036330 same patient, different vaccine dose/events.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: she got another lump with the 2nd vaccine; she had stage 2 metastatic breast cancer.; she has thrush; a throat infection; This is a spontaneous report received from a contactable consumer(patient).   A 36-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0179) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8736) on an unspecified date in May2021 and experienced lymphadenopathy. The patient informed that she got the vaccine in May2021 and her primary wouldn't get her an ultrasound or anything at all saying it was the CDC guidelines to wait for 3 months. Patient experienced a swollen lymph node right away with the 1st dose that was not going away and she got another lump with the 2nd vaccine. Patient underwent an ultrasound in Aug2021 that showed stage 2 metastatic breast cancer. Patient also has a thrush and a throat infection right now and it's hard to talk. The patient had not yet recovered from she got another lump with the 2nd vaccine' and breast cancer stage II, while outcome of other reported events was unknown.   Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101036330 same patient, different vaccine dose/events.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Breast cancer stage II, Breast mass, Candida infection, Investigation, Pharyngitis
Clinical narrative: she got another lump with the 2nd vaccine; she had stage 2 metastatic breast cancer.; she has thrush; a throat infection; This is a spontaneous report received from a contactable consumer(patient).   A 36-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0179) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8736) on an unspecified date in May2021 and experienced lymphadenopathy. The patient informed that she got the vaccine in May2021 and her primary wouldn't get her an ultrasound or anything at all saying it was the CDC guidelines to wait for 3 months. Patient experienced a swollen lymph node right away with the 1st dose that was not going away and she got another lump with the 2nd vaccine. Patient underwent an ultrasound in Aug2021 that showed stage 2 metastatic breast cancer. Patient also has a thrush and a throat infection right now and it's hard to talk. The patient had not yet recovered from she got another lump with the 2nd vaccine' and breast cancer stage II, while outcome of other reported events was unknown.   Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101036330 same patient, different vaccine dose/events.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: pt admitted to hosp with c/o cough, congestion, fever, diarrhea worsening over past 10days; positive for COVID; O2 supplementation given; remdisivir; pt is DNR; condition worsened and pt was transitioned to comfort care; she died in the hospital
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Death, Diarrhoea, Pyrexia
Clinical narrative: pt admitted to hosp with c/o cough, congestion, fever, diarrhea worsening over past 10days; positive for COVID; O2 supplementation given; remdisivir; pt is DNR; condition worsened and pt was transitioned to comfort care; she died in the hospital
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: pt admitted to hosp with c/o cough, congestion, fever, diarrhea worsening over past 10days; positive for COVID; O2 supplementation given; remdisivir; pt is DNR; condition worsened and pt was transitioned to comfort care; she died in the hospital
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Groin pain, Insomnia, Rash
Clinical narrative: typical rash from his scrotum; typical rash from his scrotum to the middle of his back.; Shingles; Femoral triangle area pain; Trouble sleeping; This case was reported by a physician via call center representative and described the occurrence of pain femoral in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2021, the patient received the 1st dose of Shingrix. On 29th August 2021, less than a day after receiving Shingrix, the patient experienced pain femoral and difficulty sleeping. On an unknown date, the patient experienced scrotal rash, rash and shingles. On an unknown date, the outcome of the pain femoral, difficulty sleeping, scrotal rash and shingles were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the pain femoral, difficulty sleeping, scrotal rash, rash and shingles to be related to Shingrix.  Additional details were provided as follows: The patient was a physician and he self-reported this case. The patient received dose of Shingrix vaccine and experienced femoral triangle area pain and trouble sleeping the evening he received the vaccine. Less than 2 months after vaccination, the patient also experienced typical rash from his scrotum to the middle of his back. Less than 2 months after vaccination, the reporter stated that the vaccine triggered a reaction to cause Shingles. The reporter stated that it had been two months, and he still had a residual rash. The reporter was inquiring if he should get the second dose of the vaccine since he had this reaction with the first dose. Provided reporter with information from Shingrix (frequently asked questions) per content regarding, if he already had Shingles could he still get vaccinated. He just had a case of shingles, how long did he had to wait to get the vaccination. The reporter stated that he was interested in information regarding patients who experienced shingles as a result of receiving the Shingrix vaccine. The reporter reported experience to VAERS. The reporter provided permission to contact his healthcare professional. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Herpes zoster, Insomnia, Rash, Scrotal dermatitis
Clinical narrative: typical rash from his scrotum; typical rash from his scrotum to the middle of his back.; Shingles; Femoral triangle area pain; Trouble sleeping; This case was reported by a physician via call center representative and described the occurrence of pain femoral in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2021, the patient received the 1st dose of Shingrix. On 29th August 2021, less than a day after receiving Shingrix, the patient experienced pain femoral and difficulty sleeping. On an unknown date, the patient experienced scrotal rash, rash and shingles. On an unknown date, the outcome of the pain femoral, difficulty sleeping, scrotal rash and shingles were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the pain femoral, difficulty sleeping, scrotal rash, rash and shingles to be related to Shingrix.  Additional details were provided as follows: The patient was a physician and he self-reported this case. The patient received dose of Shingrix vaccine and experienced femoral triangle area pain and trouble sleeping the evening he received the vaccine. Less than 2 months after vaccination, the patient also experienced typical rash from his scrotum to the middle of his back. Less than 2 months after vaccination, the reporter stated that the vaccine triggered a reaction to cause Shingles. The reporter stated that it had been two months, and he still had a residual rash. The reporter was inquiring if he should get the second dose of the vaccine since he had this reaction with the first dose. Provided reporter with information from Shingrix (frequently asked questions) per content regarding, if he already had Shingles could he still get vaccinated. He just had a case of shingles, how long did he had to wait to get the vaccination. The reporter stated that he was interested in information regarding patients who experienced shingles as a result of receiving the Shingrix vaccine. The reporter reported experience to VAERS. The reporter provided permission to contact his healthcare professional. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: At pop-up vaccination clinic. Nurse gave patient Moderna vaccine instead of Pfizer. Patient is under 18 years old. No adverse side effects noted, doctor notified, and mother with patient at the time and notified and aware of situation.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: At pop-up vaccination clinic. Nurse gave patient Moderna vaccine instead of Pfizer. Patient is under 18 years old. No adverse side effects noted, doctor notified, and mother with patient at the time and notified and aware of situation.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: At pop-up vaccination clinic nurse gave patient Moderna vaccine instead of Pfizer. Patient is under 18 years old. No adverse side effects noted, doctor notified, and mother with patient at the time and notified and aware of situation.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: At pop-up vaccination clinic nurse gave patient Moderna vaccine instead of Pfizer. Patient is under 18 years old. No adverse side effects noted, doctor notified, and mother with patient at the time and notified and aware of situation.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt brought via husband's car to ED; unresponsive in car x 15 mins; dx'd positive for COVID 5 days before coming to ED; respiratory failure; no pulse, no respiratory effort; intubated and CPR given; pt remained asystole; ACLS protocol started; pt never improved; expired in the ED
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac arrest, Death, Endotracheal intubation, Life support
Clinical narrative: pt brought via husband's car to ED; unresponsive in car x 15 mins; dx'd positive for COVID 5 days before coming to ED; respiratory failure; no pulse, no respiratory effort; intubated and CPR given; pt remained asystole; ACLS protocol started; pt never improved; expired in the ED
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulse absent, Respiratory distress, Respiratory failure, Resuscitation, SARS-CoV-2 test positive
Clinical narrative: pt brought via husband's car to ED; unresponsive in car x 15 mins; dx'd positive for COVID 5 days before coming to ED; respiratory failure; no pulse, no respiratory effort; intubated and CPR given; pt remained asystole; ACLS protocol started; pt never improved; expired in the ED
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: pt brought via husband's car to ED; unresponsive in car x 15 mins; dx'd positive for COVID 5 days before coming to ED; respiratory failure; no pulse, no respiratory effort; intubated and CPR given; pt remained asystole; ACLS protocol started; pt never improved; expired in the ED
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram ST segment abnormal, Troponin increased
Clinical narrative: Seen in ED and admitted to Hospital: 14y / male presents with chest pain, had second COVID vaccine 09/28/2021 and developed chast pain and SOB starting 9/29/2021. Pain increases with activity. Also having headache, fatigue, and myalgias.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Seen in ED and admitted to Hospital: 14y / male presents with chest pain, had second COVID vaccine 09/28/2021 and developed chast pain and SOB starting 9/29/2021. Pain increases with activity. Also having headache, fatigue, and myalgias.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain, Troponin increased
Clinical narrative: Seen in ED and admitted to Hospital: 14y / male presents with chest pain, had second COVID vaccine 09/28/2021 and developed chast pain and SOB starting 9/29/2021. Pain increases with activity. Also having headache, fatigue, and myalgias.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: pt diagnosed positive for COVID on 9/23/21 @ local pharmacy; presented to ED with worsening respiratory symptoms; Acute hypoxic respiratory failure due to COVID pneumonia; supplemental O2 supplied by high flow NC; remdisivir, antibiotics and Lovenox given; pt's condition worsened and he was placed on BiPAP mask and transferred to ICU; DNR/DNI; pt's condition continued to deteriorate; family decided on comfort care only; pt died in the hosp
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Death, General physical health deterioration
Clinical narrative: pt diagnosed positive for COVID on 9/23/21 @ local pharmacy; presented to ED with worsening respiratory symptoms; Acute hypoxic respiratory failure due to COVID pneumonia; supplemental O2 supplied by high flow NC; remdisivir, antibiotics and Lovenox given; pt's condition worsened and he was placed on BiPAP mask and transferred to ICU; DNR/DNI; pt's condition continued to deteriorate; family decided on comfort care only; pt died in the hosp
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Positive airway pressure therapy, Respiratory symptom, SARS-CoV-2 test positive
Clinical narrative: pt diagnosed positive for COVID on 9/23/21 @ local pharmacy; presented to ED with worsening respiratory symptoms; Acute hypoxic respiratory failure due to COVID pneumonia; supplemental O2 supplied by high flow NC; remdisivir, antibiotics and Lovenox given; pt's condition worsened and he was placed on BiPAP mask and transferred to ICU; DNR/DNI; pt's condition continued to deteriorate; family decided on comfort care only; pt died in the hosp
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: pt to ED with increasing SOB and productive cough x 1 wk; hx of COPD, A Fib, HTN, lung CA; hypoxic respiratory failure secondary to COVID pneumonia; given decadron and remdisivir; pt's condition worsened; O2 supplementation via NC; pt refused BiPAP; DNAR/DNI; pt condition continued to decline and he passed away in the hospital
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Death, Dyspnoea, Productive cough, Respiratory failure
Clinical narrative: pt to ED with increasing SOB and productive cough x 1 wk; hx of COPD, A Fib, HTN, lung CA; hypoxic respiratory failure secondary to COVID pneumonia; given decadron and remdisivir; pt's condition worsened; O2 supplementation via NC; pt refused BiPAP; DNAR/DNI; pt condition continued to decline and he passed away in the hospital
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Chest discomfort, Chest pain, Electrocardiogram ST segment elevation, Myocarditis, Pericarditis
Clinical narrative: 8 hours after the COVID vaccine, patient got a fever, headache, muscle pain, fatigue, chills, body aches. These symptoms lasted for about 48 hours. Then just about 4 days after the COVID vaccine, patient developed chest pains and difficulty breathing. He went to the ER where he was diagnosed with perimyocarditis.