chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: Hypotension; This is a spontaneous report from a contactable consumer (mother) or other non hcp. A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hypotension on an unspecified date (12 minutes after the injection). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Capillary disorder, Contusion
Clinical narrative: Big red spot, its look like a fresh bruise, almost like somebody punched me, its look like a broken capillaries or something; Big red spot, its look like a fresh bruise, almost like somebody punched me, its look like a broken capillaries or something; Big red spot, its look like a fresh bruise, almost like somebody punched me, its look like a broken capillaries or something; This is a spontaneous report from a contactable consumer. This consumer was reported that.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0178), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. It was reported that patient just got the second dose today about 1 o'clock and patient have a reaction to it, patient got home around 3:30 or so patient got the shot on 1:30 and home at 3:30 ad about an hour ago patient noticed that was scratching his stomach then lifted his shirt, saw a big red spot, its look like a fresh bruise, almost like somebody punched, its look like a broken capillary or something. It's a big giant red spot 3 or 4 inches across. It is on the lower part of his stomach; patient lifted his shirt up and find at lower part of his stomach this bright red spot. Patient first question is, is that on the list of side effects, has anyone else have that patient wondering what should do about it so I mean like has anyone have the specific thing?" Consumer confirmed it was the Pfizer Covid19 vaccine.Consumer was unwilling to complete the report. Hence, limited information available. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Tinnitus
Clinical narrative: This is a spontaneous report from a consumer (patient). A 35-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot#, expiry date: unknown), at the age of 35, via an unspecified route of administration, on May 5, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. May 2021, patient experienced ear ringing and palm rash. Since the vaccination, patient has not tested for COVID-19. The events did result in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of events: unspecified drug on an unknown date. The outcome of the ear ringing and palm rash: unknown (at the time of this report). The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Headache, Renal pain
Clinical narrative: chills; headache; fatigue; stabbing pain in my kidneys; acute sensation in my left sciatic nerve; tenderness; The stabbing pain in my kidneys eventually subsided and it felt very tender, almost like it was bruised around that area; This is a spontaneous report from a contactable consumer. A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EWO161), dose 2 via an unspecified route of administration, administered in left arm on 10May2021 at 11:00 (at the age of 53-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical was not reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EWO161) as dose 1, single administered in left arm on 15Apr2021 at 10:00AM (at the age of 53-years-old) for COVID-19 immunization. Concomitant medication included vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported received other medications in two weeks. No other vaccine in four weeks. Patient was very healthy with no prior health issues. No COVID prior vaccination. Patient did not have allergies. Other medical history reported as no. Facility type vaccine: other. On receiving the second dose, the day after on 11May2021 at 14:00 PM, patient had the common symptoms such as chills, headache, fatigue. However, throughout that day patient also had stabbing pain in kidneys for what felt like several hours, along with an acute sensation in left sciatic nerve. The stabbing pain in kidneys eventually subsided and it felt very tender and patient was unsure of what test should have to check if there has been any kidney damage. Almost like it was bruised around that area. 2 weeks on, there was still a tenderness there, so patient was a bit concerned that there may have been some damage. Patient had a concerned that there may have been some sort of damage to Kidneys. COVID tested post vaccination reported as no. Adverse event resulted in: Doctor or other health care professional office/clinic visit. The event was not treated. If patient recovered: Recovered with lasting effects. The outcome of the events were recovered on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatic nerve injury, Tenderness
Clinical narrative: chills; headache; fatigue; stabbing pain in my kidneys; acute sensation in my left sciatic nerve; tenderness; The stabbing pain in my kidneys eventually subsided and it felt very tender, almost like it was bruised around that area; This is a spontaneous report from a contactable consumer. A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EWO161), dose 2 via an unspecified route of administration, administered in left arm on 10May2021 at 11:00 (at the age of 53-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical was not reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EWO161) as dose 1, single administered in left arm on 15Apr2021 at 10:00AM (at the age of 53-years-old) for COVID-19 immunization. Concomitant medication included vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported received other medications in two weeks. No other vaccine in four weeks. Patient was very healthy with no prior health issues. No COVID prior vaccination. Patient did not have allergies. Other medical history reported as no. Facility type vaccine: other. On receiving the second dose, the day after on 11May2021 at 14:00 PM, patient had the common symptoms such as chills, headache, fatigue. However, throughout that day patient also had stabbing pain in kidneys for what felt like several hours, along with an acute sensation in left sciatic nerve. The stabbing pain in kidneys eventually subsided and it felt very tender and patient was unsure of what test should have to check if there has been any kidney damage. Almost like it was bruised around that area. 2 weeks on, there was still a tenderness there, so patient was a bit concerned that there may have been some damage. Patient had a concerned that there may have been some sort of damage to Kidneys. COVID tested post vaccination reported as no. Adverse event resulted in: Doctor or other health care professional office/clinic visit. The event was not treated. If patient recovered: Recovered with lasting effects. The outcome of the events were recovered on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blister, Condition aggravated, Herpes zoster, Pain
Clinical narrative: black bubbles; shingles; red spots begin to surface on the thigh/Just bigger red spots; red spot became bigger I thought it was rash, pain persists; red spots begin to surface on the thigh; Back pain; Thigh pain; This is a spontaneous report from a contactable consumer or other non hcp (patient) and physician. A 28-year-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 15May2021 at 08:30 AM (at the age of 28-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included known allergies: possibly lutein from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 17Apr2021 at 11:00 AM (at the age of 28-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. The patient experienced back pain, thigh pain on an unspecified date in 2021; red spots begin to surface on the thigh on 16May2021; red spot became bigger I thought it was rash, pain persists on 17May2021; red spots begin to surface on the thigh/just bigger red spots on 18May2021; black bubbles, shingles on 20May2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event: On 13May2021 (3 Weeks after first covid vaccine shot), I started to feel skin pain on the area above right kneecap. Then I felt nerve pain on the same side of leg. 14May2021 I couldn't sit down as I felt occasional lumbar pain. I even went to Orthopaedics and they said no trouble found. Skin pain spreaded through the whole body. 15May2021 I had second shot of Pfizer, still back pain and thigh pain. 16May2021 I saw red spots begin to surface on the thigh. 17May2021red spot became bigger I thought it was rash, pain persists. 18May2021the red spots looks out of control, I scheduled the next available appointment for primary care (2days later) 19May2021Just bigger red spots every time I take off my pants. 20May2021 black bubbles appeared in the morning, and I got to finally go to appointment at noon, diagnosed as shingles. The patient received unspecified treatment for the event shingles. Outcome of all the events was recovering.  Follow-up: Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular
Clinical narrative: black bubbles; shingles; red spots begin to surface on the thigh/Just bigger red spots; red spot became bigger I thought it was rash, pain persists; red spots begin to surface on the thigh; Back pain; Thigh pain; This is a spontaneous report from a contactable consumer or other non hcp (patient) and physician. A 28-year-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 15May2021 at 08:30 AM (at the age of 28-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included known allergies: possibly lutein from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 17Apr2021 at 11:00 AM (at the age of 28-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. The patient experienced back pain, thigh pain on an unspecified date in 2021; red spots begin to surface on the thigh on 16May2021; red spot became bigger I thought it was rash, pain persists on 17May2021; red spots begin to surface on the thigh/just bigger red spots on 18May2021; black bubbles, shingles on 20May2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event: On 13May2021 (3 Weeks after first covid vaccine shot), I started to feel skin pain on the area above right kneecap. Then I felt nerve pain on the same side of leg. 14May2021 I couldn't sit down as I felt occasional lumbar pain. I even went to Orthopaedics and they said no trouble found. Skin pain spreaded through the whole body. 15May2021 I had second shot of Pfizer, still back pain and thigh pain. 16May2021 I saw red spots begin to surface on the thigh. 17May2021red spot became bigger I thought it was rash, pain persists. 18May2021the red spots looks out of control, I scheduled the next available appointment for primary care (2days later) 19May2021Just bigger red spots every time I take off my pants. 20May2021 black bubbles appeared in the morning, and I got to finally go to appointment at noon, diagnosed as shingles. The patient received unspecified treatment for the event shingles. Outcome of all the events was recovering.  Follow-up: Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Decreased appetite, Dehydration, Fatigue, Hepatic enzyme increased
Clinical narrative: nausea; fatigue; full body rash; loss of appetite; vomiting; unable to keep liquids down; Bloodwork shows elevated liver enzymes; This is a spontaneous report from a contactable consumer. A 65-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 as single dose (at the age of 65-year-old) for COVID-19 immunization. Medical history included elevated blood pressure and cholesterol. Concomitant medication included atorvastatin calcium (LIPITOR), unspecified BP meds (MANUFACTURER UNKNOWN), vitamin D nos (VITAMIN D); all since unknown dates and for unknown indications. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05May2021 at 15:00, patient experienced nausea, fatigue, full body rash, loss of appetite, vomiting, unable to keep liquids down and bloodwork showing elevated liver enzymes. The patient underwent lab tests and procedures which included blood test or work which showed elevated liver enzymes on 05May2021. The patient received treatment for the reported events which included, bloodwork, Benadryl and cortisone cream. The adverse events resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events nausea, fatigue, body rash, loss of appetite, vomiting, unable to keep liquids down and bloodwork showing elevated liver enzymes were not recovered at the time of this report.   The lot number for the vaccine [BNT162b2], was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: nausea; fatigue; full body rash; loss of appetite; vomiting; unable to keep liquids down; Bloodwork shows elevated liver enzymes; This is a spontaneous report from a contactable consumer. A 65-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 as single dose (at the age of 65-year-old) for COVID-19 immunization. Medical history included elevated blood pressure and cholesterol. Concomitant medication included atorvastatin calcium (LIPITOR), unspecified BP meds (MANUFACTURER UNKNOWN), vitamin D nos (VITAMIN D); all since unknown dates and for unknown indications. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05May2021 at 15:00, patient experienced nausea, fatigue, full body rash, loss of appetite, vomiting, unable to keep liquids down and bloodwork showing elevated liver enzymes. The patient underwent lab tests and procedures which included blood test or work which showed elevated liver enzymes on 05May2021. The patient received treatment for the reported events which included, bloodwork, Benadryl and cortisone cream. The adverse events resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events nausea, fatigue, body rash, loss of appetite, vomiting, unable to keep liquids down and bloodwork showing elevated liver enzymes were not recovered at the time of this report.   The lot number for the vaccine [BNT162b2], was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaemia, Rash pruritic
Clinical narrative: Hyperemic, pruritic, blanching rash on the arms, legs, face and torso; Hyperemic, pruritic, blanching rash on the arms, legs, face and torso; This is a spontaneous report from a contactable physician. A 19-year-old non-pregnant female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 20May2021 (age at the time of vaccination was 19 years) as dose 2, single for covid-19 immunisation. Other medical history was reported as none and known allergies were reported as no. List of any other medications the patient received within 2 weeks of vaccination and concomitant medications were reported as no. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in May2021 (in 24 hrs after the second Pfizer vaccine against Covid-19), the patient experienced hyperemic, pruritic, blanching rash on the arms, legs, face and torso. Serious/ Seriousness criteria-Results in death/ Seriousness criteria-Life threatening/ Seriousness criteria-Caused/prolonged hospitalization/ Seriousness criteria-Disabling/Incapacitating/ Seriousness criteria-Congenital anomaly/birth defect were reported as no. Reportedly, the adverse event result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hyperemic, pruritic, blanching rash on the arms, legs, face and torso which included Zyrtec 10 mg PO once a day. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: diarrhea; Fever of 101; chills; very fatigued; some severe headaches; not felt very well; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 01Feb2021 (at the age of 76 years old) as dose 2, single for COVID-19 immunisation. No medical history reported. Concomitant medications included gabapentin from Apr2020; diltiazem hydrochloride (DILT-XR) from an unspecified start date; losartan from Apr2020 and ezetimibe (ZETIA) from an unspecified start date - all ongoing and taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: not reported), via an unspecified route of administration, administered in left arm on 11Jan2021 at 13:15 (at the age of 75 years old) as dose 1, single for COVID-19 immunisation and experienced very painful stiff neck and rapid heartbeat. On 01Feb2021, the patient had fever of 101 and chills overnight on the "1st to second" (as reported). The patient was then fine for a day then had the same thing overnight. On 04Feb2021, the patient had another fever of 101 and diarrhea. Furthermore, the patient reported to be "very fatigued" for the next week on an unspecified date in Feb2021. Since then, on an unspecified date in Feb2021, the patient had some severe headaches and have not felt very well since taking the second vaccine. Events did not result to emergency room nor physician office visit. Outcome of events severe headache and not felt very well was not recovered and unknown for the rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: diarrhea; Fever of 101; chills; very fatigued; some severe headaches; not felt very well; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 01Feb2021 (at the age of 76 years old) as dose 2, single for COVID-19 immunisation. No medical history reported. Concomitant medications included gabapentin from Apr2020; diltiazem hydrochloride (DILT-XR) from an unspecified start date; losartan from Apr2020 and ezetimibe (ZETIA) from an unspecified start date - all ongoing and taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: not reported), via an unspecified route of administration, administered in left arm on 11Jan2021 at 13:15 (at the age of 75 years old) as dose 1, single for COVID-19 immunisation and experienced very painful stiff neck and rapid heartbeat. On 01Feb2021, the patient had fever of 101 and chills overnight on the "1st to second" (as reported). The patient was then fine for a day then had the same thing overnight. On 04Feb2021, the patient had another fever of 101 and diarrhea. Furthermore, the patient reported to be "very fatigued" for the next week on an unspecified date in Feb2021. Since then, on an unspecified date in Feb2021, the patient had some severe headaches and have not felt very well since taking the second vaccine. Events did not result to emergency room nor physician office visit. Outcome of events severe headache and not felt very well was not recovered and unknown for the rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the first shot, I only experienced arm pain.; This is a spontaneous report from a contactable consumer or other non hcp.  A 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09May2021, at 18:00 (Batch/Lot Number: EW0169) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not test for covid prior to vaccination, and post vaccination. Medical history was none. No known allergies. The patient's concomitant medications were not reported. On an unspecified date in May2021, patient stated after the first shot, I only experienced arm pain. Patient received no treatment. The outcome of the event was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Dehydration, Diarrhoea, Fatigue
Clinical narrative: diarrhea worsened dramatically; bloating; discomfort; Currently still occurs 5x daily; weight loss; fatigue; dehydration; loss of muscle mass; This is a spontaneous report from a contactable Other HCP (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 7533), via Intramuscular route of administration, administrated in Left arm on 10Apr2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 6995), via Intramuscular route of administration, administrated in Left arm on 20Mar2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization and experienced diarrhea. The patient's medical history included Pre-diabetes/glucose intolerance, peripheral neuropathy, PACs (Premature atrial contractions), PVCs (Premature ventricular contractions), and osteopenia. The patient's concomitant medications included Metformin, Januvia, atorvastatin, valacyclovir HCL, famotidine, calcium citrate, multivitamin, and vitamin D3. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. Patient did covid tested post vaccination. On an unspecified date, the patient experienced diarrhea worsened dramatically, bloating, discomfort, currently still occurs 5x daily, weight loss, fatigue, dehydration, and loss of muscle mass. On 29Apr2021, the patient underwent lab tests and procedures which included (polymerase chain reaction) Nasal Swab, SARS-CoV-2 test: Negative, Nasal Swab. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received treatment as a result of adverse events which included Antibiotic therapy, symptomatic treatment, and FODMAP diet. The outcome for all the events was not recovered.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650278 same patient/reporter/product, different event
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Frequent bowel movements, Muscle atrophy, SARS-CoV-2 test, Weight decreased
Clinical narrative: diarrhea worsened dramatically; bloating; discomfort; Currently still occurs 5x daily; weight loss; fatigue; dehydration; loss of muscle mass; This is a spontaneous report from a contactable Other HCP (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 7533), via Intramuscular route of administration, administrated in Left arm on 10Apr2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 6995), via Intramuscular route of administration, administrated in Left arm on 20Mar2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization and experienced diarrhea. The patient's medical history included Pre-diabetes/glucose intolerance, peripheral neuropathy, PACs (Premature atrial contractions), PVCs (Premature ventricular contractions), and osteopenia. The patient's concomitant medications included Metformin, Januvia, atorvastatin, valacyclovir HCL, famotidine, calcium citrate, multivitamin, and vitamin D3. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. Patient did covid tested post vaccination. On an unspecified date, the patient experienced diarrhea worsened dramatically, bloating, discomfort, currently still occurs 5x daily, weight loss, fatigue, dehydration, and loss of muscle mass. On 29Apr2021, the patient underwent lab tests and procedures which included (polymerase chain reaction) Nasal Swab, SARS-CoV-2 test: Negative, Nasal Swab. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received treatment as a result of adverse events which included Antibiotic therapy, symptomatic treatment, and FODMAP diet. The outcome for all the events was not recovered.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650278 same patient/reporter/product, different event
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest pain, Computerised tomogram thorax, Condition aggravated, Electrocardiogram abnormal
Clinical narrative: diarrhea worsened dramatically; bloating; discomfort; Currently still occurs 5x daily; weight loss; fatigue; dehydration; loss of muscle mass; This is a spontaneous report from a contactable Other HCP (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 7533), via Intramuscular route of administration, administrated in Left arm on 10Apr2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 6995), via Intramuscular route of administration, administrated in Left arm on 20Mar2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization and experienced diarrhea. The patient's medical history included Pre-diabetes/glucose intolerance, peripheral neuropathy, PACs (Premature atrial contractions), PVCs (Premature ventricular contractions), and osteopenia. The patient's concomitant medications included Metformin, Januvia, atorvastatin, valacyclovir HCL, famotidine, calcium citrate, multivitamin, and vitamin D3. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. Patient did covid tested post vaccination. On an unspecified date, the patient experienced diarrhea worsened dramatically, bloating, discomfort, currently still occurs 5x daily, weight loss, fatigue, dehydration, and loss of muscle mass. On 29Apr2021, the patient underwent lab tests and procedures which included (polymerase chain reaction) Nasal Swab, SARS-CoV-2 test: Negative, Nasal Swab. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received treatment as a result of adverse events which included Antibiotic therapy, symptomatic treatment, and FODMAP diet. The outcome for all the events was not recovered.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650278 same patient/reporter/product, different event
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Painful respiration, Pericarditis, Pyrexia, Scan with contrast
Clinical narrative: diarrhea worsened dramatically; bloating; discomfort; Currently still occurs 5x daily; weight loss; fatigue; dehydration; loss of muscle mass; This is a spontaneous report from a contactable Other HCP (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 7533), via Intramuscular route of administration, administrated in Left arm on 10Apr2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 6995), via Intramuscular route of administration, administrated in Left arm on 20Mar2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization and experienced diarrhea. The patient's medical history included Pre-diabetes/glucose intolerance, peripheral neuropathy, PACs (Premature atrial contractions), PVCs (Premature ventricular contractions), and osteopenia. The patient's concomitant medications included Metformin, Januvia, atorvastatin, valacyclovir HCL, famotidine, calcium citrate, multivitamin, and vitamin D3. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. Patient did covid tested post vaccination. On an unspecified date, the patient experienced diarrhea worsened dramatically, bloating, discomfort, currently still occurs 5x daily, weight loss, fatigue, dehydration, and loss of muscle mass. On 29Apr2021, the patient underwent lab tests and procedures which included (polymerase chain reaction) Nasal Swab, SARS-CoV-2 test: Negative, Nasal Swab. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received treatment as a result of adverse events which included Antibiotic therapy, symptomatic treatment, and FODMAP diet. The outcome for all the events was not recovered.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650278 same patient/reporter/product, different event
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Tremor
Clinical narrative: diarrhea worsened dramatically; bloating; discomfort; Currently still occurs 5x daily; weight loss; fatigue; dehydration; loss of muscle mass; This is a spontaneous report from a contactable Other HCP (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 7533), via Intramuscular route of administration, administrated in Left arm on 10Apr2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 6995), via Intramuscular route of administration, administrated in Left arm on 20Mar2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization and experienced diarrhea. The patient's medical history included Pre-diabetes/glucose intolerance, peripheral neuropathy, PACs (Premature atrial contractions), PVCs (Premature ventricular contractions), and osteopenia. The patient's concomitant medications included Metformin, Januvia, atorvastatin, valacyclovir HCL, famotidine, calcium citrate, multivitamin, and vitamin D3. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. Patient did covid tested post vaccination. On an unspecified date, the patient experienced diarrhea worsened dramatically, bloating, discomfort, currently still occurs 5x daily, weight loss, fatigue, dehydration, and loss of muscle mass. On 29Apr2021, the patient underwent lab tests and procedures which included (polymerase chain reaction) Nasal Swab, SARS-CoV-2 test: Negative, Nasal Swab. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received treatment as a result of adverse events which included Antibiotic therapy, symptomatic treatment, and FODMAP diet. The outcome for all the events was not recovered.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650278 same patient/reporter/product, different event
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Aches; Low grade fever of 100-101; Chills; Vomiting; Nausea; This is a spontaneous report received from a contactable consumer or other non hcp. A 15-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 03Jun2021 09:00,at the age of 15 years old,as Dose 2,single for covid-19 immunization.The patient medical history was not reported.The patient experienced aches, low grade fever of 100-101 , chills, vomiting and nausea on 03Jun2021 16:00.The patient underwent lab tests and procedures which included body temperature: 100-101 on 04Jun2021.The patient was not diagnosed for covid prior vaccination and not tested for covid post vaccination.The patient reported no allergies.The patient received no treatment for the event.The outcome of the event was not recovered.  Follow-up (23Jul2021): This is a follow-up spontaneous report received from a contactable other HCP. This other HCP reported in response to HCP letter sent, in which included that patient reported adverse event with use of the Pfizer covid vaccine.  Information on the lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Aches; Low grade fever of 100-101; Chills; Vomiting; Nausea; This is a spontaneous report received from a contactable consumer or other non hcp. A 15-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 03Jun2021 09:00,at the age of 15 years old,as Dose 2,single for covid-19 immunization.The patient medical history was not reported.The patient experienced aches, low grade fever of 100-101 , chills, vomiting and nausea on 03Jun2021 16:00.The patient underwent lab tests and procedures which included body temperature: 100-101 on 04Jun2021.The patient was not diagnosed for covid prior vaccination and not tested for covid post vaccination.The patient reported no allergies.The patient received no treatment for the event.The outcome of the event was not recovered.  Follow-up (23Jul2021): This is a follow-up spontaneous report received from a contactable other HCP. This other HCP reported in response to HCP letter sent, in which included that patient reported adverse event with use of the Pfizer covid vaccine.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Anxiety, Depression, Dysmenorrhoea, Fatigue
Clinical narrative: headache; bloating; mood swings; lethargy; started an abnormal length of spotting (breakthrough bleeding); feel tired; feverish; brought on my period when I haven't had one previously since being on Nexplanon in Jan/ altered menstrual cycle after 2nd dose; I am spotting between my period; Dose Number: 1 # Date of start of drug: 28Apr2021/ Dose Number: 2 # Date of start of drug: 15May2021; anxiety; depression; uncertainty; My cramps ere unusual compared to my normal cycle; This is a spontaneous report from a contactable consumer (Patient). A 29-year-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0173), intramuscular, administered in Arm Left on 15May2021 10:30 (at age of 29 years old) as single dose for COVID-19 immunisation. Medical history included Asthma from 1993 and ongoing, PCOS (Polycystic ovarian syndrome) from Jun2021 and ongoing, Known allergies: Raw Apples, Known allergies: Sulfa drugs. There were no concomitant medications. No other vaccine in four weeks. COVID prior vaccination. No COVID tested post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0170), Intramuscular at left arm on 28Apr2021 01:30 PM (at age of 29 years old) as single dose for COVID-19 immunisation, and The 1st dose made patient feel extremely fatigued with 101 fever & no appetite & head/body aches. The patient had Nexplanon inserted 28Jan2021.The 2nd dose made patient feel tired & feverish, it also brought on patient's period when haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose (Seriousness criteria: Not Serious). Since my 2nd vaccination, patient was spotting between period. All above events started on 21May2021 07:00 AM. No treatment for above events. Period started a week earlier, lasting a few days longer than normal; start 21May, end 26May. Nine days later (24May2021) started an abnormal length of spotting (breakthrough bleeding). Spotting started on 05Jun and ended 28Jun with a brief day of spotting on 03Jul. During these weeks of spotting patient (Jun2021) experienced headache, bloating, mood swings, and lethargy. In 2021, There were periods of strong anxiety, depression and uncertainty. Patient's cramps were unusual compared to normal cycle. Altered menstrual cycle after 2nd dose had Physician office visit. The outcome of the events feel tired & feverish, spotting between my period was Not recovered, for brought on my period when I haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose was recovering, for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Inappropriate schedule of product administration, Intermenstrual bleeding, Lethargy
Clinical narrative: headache; bloating; mood swings; lethargy; started an abnormal length of spotting (breakthrough bleeding); feel tired; feverish; brought on my period when I haven't had one previously since being on Nexplanon in Jan/ altered menstrual cycle after 2nd dose; I am spotting between my period; Dose Number: 1 # Date of start of drug: 28Apr2021/ Dose Number: 2 # Date of start of drug: 15May2021; anxiety; depression; uncertainty; My cramps ere unusual compared to my normal cycle; This is a spontaneous report from a contactable consumer (Patient). A 29-year-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0173), intramuscular, administered in Arm Left on 15May2021 10:30 (at age of 29 years old) as single dose for COVID-19 immunisation. Medical history included Asthma from 1993 and ongoing, PCOS (Polycystic ovarian syndrome) from Jun2021 and ongoing, Known allergies: Raw Apples, Known allergies: Sulfa drugs. There were no concomitant medications. No other vaccine in four weeks. COVID prior vaccination. No COVID tested post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0170), Intramuscular at left arm on 28Apr2021 01:30 PM (at age of 29 years old) as single dose for COVID-19 immunisation, and The 1st dose made patient feel extremely fatigued with 101 fever & no appetite & head/body aches. The patient had Nexplanon inserted 28Jan2021.The 2nd dose made patient feel tired & feverish, it also brought on patient's period when haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose (Seriousness criteria: Not Serious). Since my 2nd vaccination, patient was spotting between period. All above events started on 21May2021 07:00 AM. No treatment for above events. Period started a week earlier, lasting a few days longer than normal; start 21May, end 26May. Nine days later (24May2021) started an abnormal length of spotting (breakthrough bleeding). Spotting started on 05Jun and ended 28Jun with a brief day of spotting on 03Jul. During these weeks of spotting patient (Jun2021) experienced headache, bloating, mood swings, and lethargy. In 2021, There were periods of strong anxiety, depression and uncertainty. Patient's cramps were unusual compared to normal cycle. Altered menstrual cycle after 2nd dose had Physician office visit. The outcome of the events feel tired & feverish, spotting between my period was Not recovered, for brought on my period when I haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose was recovering, for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Mood swings, Pyrexia, Vaginal haemorrhage
Clinical narrative: headache; bloating; mood swings; lethargy; started an abnormal length of spotting (breakthrough bleeding); feel tired; feverish; brought on my period when I haven't had one previously since being on Nexplanon in Jan/ altered menstrual cycle after 2nd dose; I am spotting between my period; Dose Number: 1 # Date of start of drug: 28Apr2021/ Dose Number: 2 # Date of start of drug: 15May2021; anxiety; depression; uncertainty; My cramps ere unusual compared to my normal cycle; This is a spontaneous report from a contactable consumer (Patient). A 29-year-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0173), intramuscular, administered in Arm Left on 15May2021 10:30 (at age of 29 years old) as single dose for COVID-19 immunisation. Medical history included Asthma from 1993 and ongoing, PCOS (Polycystic ovarian syndrome) from Jun2021 and ongoing, Known allergies: Raw Apples, Known allergies: Sulfa drugs. There were no concomitant medications. No other vaccine in four weeks. COVID prior vaccination. No COVID tested post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0170), Intramuscular at left arm on 28Apr2021 01:30 PM (at age of 29 years old) as single dose for COVID-19 immunisation, and The 1st dose made patient feel extremely fatigued with 101 fever & no appetite & head/body aches. The patient had Nexplanon inserted 28Jan2021.The 2nd dose made patient feel tired & feverish, it also brought on patient's period when haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose (Seriousness criteria: Not Serious). Since my 2nd vaccination, patient was spotting between period. All above events started on 21May2021 07:00 AM. No treatment for above events. Period started a week earlier, lasting a few days longer than normal; start 21May, end 26May. Nine days later (24May2021) started an abnormal length of spotting (breakthrough bleeding). Spotting started on 05Jun and ended 28Jun with a brief day of spotting on 03Jul. During these weeks of spotting patient (Jun2021) experienced headache, bloating, mood swings, and lethargy. In 2021, There were periods of strong anxiety, depression and uncertainty. Patient's cramps were unusual compared to normal cycle. Altered menstrual cycle after 2nd dose had Physician office visit. The outcome of the events feel tired & feverish, spotting between my period was Not recovered, for brought on my period when I haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose was recovering, for other events was unknown.  No follow-up attempts are possible. No further information is expected.