chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Vaccination site movement impairment
Clinical narrative: not being able to lift my left arm higher than my shoulder.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, via an unspecified route of administration, administered in Arm Left on 16May2021 12:00 (Batch/Lot Number: EW0185) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient stated, "I do have fibromyalgia so I don't know if this is causing part of the reaction." Concomitant medication included levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced vaccination site movement impairment and blood pressure decreased and morphine and experienced drug hypersensitivity. The patient stated, "About 4 weeks after the second dosage, I started having the same symptom of not being able to lift my left arm higher than my shoulder. This has continued for the last month and is still happening now" on Jun2021. The patient underwent lab tests and procedures which included blood pressure measurement: dropped on Apr2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neuritis cranial, Pain
Clinical narrative: Right occipital nerve inflammation; Unilateral radiating pain from base of neck to tip of ear for 3 days; This is a spontaneous report received from a contactable other healthcare professional (patient). A 40-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Batch/Lot Number: EN6199) as dose 1, single for covid-19 immunisation. Medical history included seasonal allergies and sciatica like pain last experienced during pregnancy over 5 years ago. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included ibuprofen (ADVIL) and multivitamin [vitamins nos] (MULTIVITAMIN) both taken for an unspecified indication, start and stop date were not reported. On 17Mar2021, approximately 7 days after first dose, the patient experienced right occipital nerve inflammation and unilateral radiating pain from base of neck to tip of ear for 3 days. The patient received ibuprofen and gabapentin as treatment for the event however non-responsive to pain medications and resolved on its own. The event required physician office visit. The outcome of the events was recovered on unspecified date in 2021.  Follow-up (27Jul2021): Follow-up attempts are completed. No further information is expected.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyslexia, Fatigue, Feeling abnormal
Clinical narrative: Seizure; headache; chills; lethargic; diarrhea; I've had problems with sight; brain fog; I cannot spell words or recall  thing; I cannot spell words or recall  thing; tired; This is a spontaneous report from a non-contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:00 (Batch/Lot Number: EN 6206) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 (Batch/Lot Number: EN ER9730) as dose 2, single for COVID-19 immunization. Medical history included Hashimoto, allergies to eggs and nuts. Concomitant medications included levothyroxine; ascorbic acid (VIT C); vit d [vitamin d nos] (VIT D); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced seizure (which she never had) headache, chills, lethargic, diarrhea. Since 09Mar2021, she had problems with sight, brain fog, (overnight) she cannot spell words or recall things and was constantly tired. The events occurred on 09Mar2021 18:00. No treatment given. The patient had no prior vaccination and was not tested for COVID post vaccination. Prior vaccination, the patient was not diagnosed with COVID-19. The outcome of the events recovered with sequel/ lasting effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Memory impairment, Seizure, Visual impairment
Clinical narrative: Seizure; headache; chills; lethargic; diarrhea; I've had problems with sight; brain fog; I cannot spell words or recall  thing; I cannot spell words or recall  thing; tired; This is a spontaneous report from a non-contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:00 (Batch/Lot Number: EN 6206) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 (Batch/Lot Number: EN ER9730) as dose 2, single for COVID-19 immunization. Medical history included Hashimoto, allergies to eggs and nuts. Concomitant medications included levothyroxine; ascorbic acid (VIT C); vit d [vitamin d nos] (VIT D); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced seizure (which she never had) headache, chills, lethargic, diarrhea. Since 09Mar2021, she had problems with sight, brain fog, (overnight) she cannot spell words or recall things and was constantly tired. The events occurred on 09Mar2021 18:00. No treatment given. The patient had no prior vaccination and was not tested for COVID post vaccination. Prior vaccination, the patient was not diagnosed with COVID-19. The outcome of the events recovered with sequel/ lasting effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood iron decreased, Cardiac disorder, Cardiovascular evaluation, Haematemesis
Clinical narrative: My face, tongue, and throat swelled; My face, tongue, and throat swelled; My face, tongue, and throat swelled; I had a high, persistent fever; My body felt numb; Couldn't stop shaking; I have had severe pulmonary and heart issues; I have had severe pulmonary and heart issues; Severe electrical-like pain in my left leg and occasionally my right; Vomited blood and bile; Vomited blood and bile; I lost 15 pounds; My iron levels are low; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN8730), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (at the age of 18-years-old) at dose 2, single for COVID-19 immunization. Medical history included asthma and allergic rhinitis. She has known allergies to egg, tree nut, sulfa, and penicillin and mentioned that she experienced anaphylaxis to all these. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Concomitant medications included montelukast, triamcinolone acetonide (NASACORT), salbutamol (ALBUTEROL), ascorbic acid (VITAMIN C), and colecalciferol (VITAMIN D). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received sulfur and experienced allergy causing anaphylaxis. She also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration in left arm on 07Mar2021 at 10:00 (at the age of 18-years-old) at dose 1, single for COVID-19 immunization and did not experience any severe side effects. Facility where the most recent COVID-19 vaccine was administered was reported as other. During the first dose, the patient didn't have severe side effects. She has a history of anaphylaxis, and on 29Mar2021 at 00:00 (also reported as about 12 hours after the second dose), her face, tongue, and throat swelled. She had a high, persistent fever. Her body felt numb and couldn't stop shaking. Since then, she had severe pulmonary and heart issues. Her body uncontrollably shakes and jolts. She has severe electrical-like pain in her left leg and occasionally on her right. She vomited blood and bile to the point where she lost 15 pounds. Her iron levels were low because of it. She mentioned that she was still being tested for cardiovascular problem with unknown result on an unspecified date in 2021. Therapeutic measures were taken as a result of the events. The events required doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were reported as serious causing disability.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lung disorder, Pain in extremity, Pharyngeal swelling, Pyrexia
Clinical narrative: My face, tongue, and throat swelled; My face, tongue, and throat swelled; My face, tongue, and throat swelled; I had a high, persistent fever; My body felt numb; Couldn't stop shaking; I have had severe pulmonary and heart issues; I have had severe pulmonary and heart issues; Severe electrical-like pain in my left leg and occasionally my right; Vomited blood and bile; Vomited blood and bile; I lost 15 pounds; My iron levels are low; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN8730), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (at the age of 18-years-old) at dose 2, single for COVID-19 immunization. Medical history included asthma and allergic rhinitis. She has known allergies to egg, tree nut, sulfa, and penicillin and mentioned that she experienced anaphylaxis to all these. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Concomitant medications included montelukast, triamcinolone acetonide (NASACORT), salbutamol (ALBUTEROL), ascorbic acid (VITAMIN C), and colecalciferol (VITAMIN D). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received sulfur and experienced allergy causing anaphylaxis. She also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration in left arm on 07Mar2021 at 10:00 (at the age of 18-years-old) at dose 1, single for COVID-19 immunization and did not experience any severe side effects. Facility where the most recent COVID-19 vaccine was administered was reported as other. During the first dose, the patient didn't have severe side effects. She has a history of anaphylaxis, and on 29Mar2021 at 00:00 (also reported as about 12 hours after the second dose), her face, tongue, and throat swelled. She had a high, persistent fever. Her body felt numb and couldn't stop shaking. Since then, she had severe pulmonary and heart issues. Her body uncontrollably shakes and jolts. She has severe electrical-like pain in her left leg and occasionally on her right. She vomited blood and bile to the point where she lost 15 pounds. Her iron levels were low because of it. She mentioned that she was still being tested for cardiovascular problem with unknown result on an unspecified date in 2021. Therapeutic measures were taken as a result of the events. The events required doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were reported as serious causing disability.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Tremor, Vomiting, Weight
Clinical narrative: My face, tongue, and throat swelled; My face, tongue, and throat swelled; My face, tongue, and throat swelled; I had a high, persistent fever; My body felt numb; Couldn't stop shaking; I have had severe pulmonary and heart issues; I have had severe pulmonary and heart issues; Severe electrical-like pain in my left leg and occasionally my right; Vomited blood and bile; Vomited blood and bile; I lost 15 pounds; My iron levels are low; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN8730), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (at the age of 18-years-old) at dose 2, single for COVID-19 immunization. Medical history included asthma and allergic rhinitis. She has known allergies to egg, tree nut, sulfa, and penicillin and mentioned that she experienced anaphylaxis to all these. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Concomitant medications included montelukast, triamcinolone acetonide (NASACORT), salbutamol (ALBUTEROL), ascorbic acid (VITAMIN C), and colecalciferol (VITAMIN D). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received sulfur and experienced allergy causing anaphylaxis. She also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration in left arm on 07Mar2021 at 10:00 (at the age of 18-years-old) at dose 1, single for COVID-19 immunization and did not experience any severe side effects. Facility where the most recent COVID-19 vaccine was administered was reported as other. During the first dose, the patient didn't have severe side effects. She has a history of anaphylaxis, and on 29Mar2021 at 00:00 (also reported as about 12 hours after the second dose), her face, tongue, and throat swelled. She had a high, persistent fever. Her body felt numb and couldn't stop shaking. Since then, she had severe pulmonary and heart issues. Her body uncontrollably shakes and jolts. She has severe electrical-like pain in her left leg and occasionally on her right. She vomited blood and bile to the point where she lost 15 pounds. Her iron levels were low because of it. She mentioned that she was still being tested for cardiovascular problem with unknown result on an unspecified date in 2021. Therapeutic measures were taken as a result of the events. The events required doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were reported as serious causing disability.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: My face, tongue, and throat swelled; My face, tongue, and throat swelled; My face, tongue, and throat swelled; I had a high, persistent fever; My body felt numb; Couldn't stop shaking; I have had severe pulmonary and heart issues; I have had severe pulmonary and heart issues; Severe electrical-like pain in my left leg and occasionally my right; Vomited blood and bile; Vomited blood and bile; I lost 15 pounds; My iron levels are low; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN8730), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (at the age of 18-years-old) at dose 2, single for COVID-19 immunization. Medical history included asthma and allergic rhinitis. She has known allergies to egg, tree nut, sulfa, and penicillin and mentioned that she experienced anaphylaxis to all these. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Concomitant medications included montelukast, triamcinolone acetonide (NASACORT), salbutamol (ALBUTEROL), ascorbic acid (VITAMIN C), and colecalciferol (VITAMIN D). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received sulfur and experienced allergy causing anaphylaxis. She also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration in left arm on 07Mar2021 at 10:00 (at the age of 18-years-old) at dose 1, single for COVID-19 immunization and did not experience any severe side effects. Facility where the most recent COVID-19 vaccine was administered was reported as other. During the first dose, the patient didn't have severe side effects. She has a history of anaphylaxis, and on 29Mar2021 at 00:00 (also reported as about 12 hours after the second dose), her face, tongue, and throat swelled. She had a high, persistent fever. Her body felt numb and couldn't stop shaking. Since then, she had severe pulmonary and heart issues. Her body uncontrollably shakes and jolts. She has severe electrical-like pain in her left leg and occasionally on her right. She vomited blood and bile to the point where she lost 15 pounds. Her iron levels were low because of it. She mentioned that she was still being tested for cardiovascular problem with unknown result on an unspecified date in 2021. Therapeutic measures were taken as a result of the events. The events required doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were reported as serious causing disability.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase, Blood alkaline phosphatase increased, Computerised tomogram, Computerised tomogram abnormal, Feeling abnormal
Clinical narrative: Alkaline Phosphatase Level 269/Alkaline Phosphatase Level 444; Started feeling bad, feeling not like herself/Felt like something was inside pushing or kneading for a couple of weeks; Abnormal Mammogram; Abnormal CT Scan; Abnormal PET Scan; Doctors saying it looks like cancer; Looks like lungs are collapsing; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 26Feb2021 as dose 2, single for covid-19 immunization at a hospital. Medical history included breast cancer from an unknown date and not ongoing recovered after radiation 6 years ago. There were no concomitant medications. No additional vaccines administered on the same day. No vaccinations within four weeks prior to the first administration date, states she does not normally get vaccines. The patient previously received the first dose of BNT162B2 on 05Feb2021 for COVID-19 immunization. On an unspecified date in 2021 after the last vaccination, the patient was having a lot of tests now and the doctors saying it looks like cancer, one of her test looked like her lungs were collapsing, she started feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks, had abnormal mammogram, abnormal CT scan, and abnormal PET scan. The patient's alkaline phosphatase level was 71 on Oct2020, 269 on 13May2021, and then 444 on 07Jul2021 and her doctor was concerned about these results. The events required physician's office visit for consultation. The patient underwent lab tests and procedures which included blood alkaline phosphatase: 71 on Oct2020, blood alkaline phosphatase: 269 on 13May2021, blood alkaline phosphatase: 444 on 07Jul2021, computerised tomogram: abnormal on 2021, test: lung were collapsing   on 2021, mammogram: normal on Jan2021 nothing was wrong, mammogram: abnormal on 2021, positron emission tomogram: abnormal on 2021. The patient has a biopsy scheduled for next week on her breast and lungs. The outcome of the event feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks was not recovered while for the rest of the events was unknown.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Mammogram, Mammogram abnormal, Neoplasm malignant, Pneumothorax
Clinical narrative: Alkaline Phosphatase Level 269/Alkaline Phosphatase Level 444; Started feeling bad, feeling not like herself/Felt like something was inside pushing or kneading for a couple of weeks; Abnormal Mammogram; Abnormal CT Scan; Abnormal PET Scan; Doctors saying it looks like cancer; Looks like lungs are collapsing; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 26Feb2021 as dose 2, single for covid-19 immunization at a hospital. Medical history included breast cancer from an unknown date and not ongoing recovered after radiation 6 years ago. There were no concomitant medications. No additional vaccines administered on the same day. No vaccinations within four weeks prior to the first administration date, states she does not normally get vaccines. The patient previously received the first dose of BNT162B2 on 05Feb2021 for COVID-19 immunization. On an unspecified date in 2021 after the last vaccination, the patient was having a lot of tests now and the doctors saying it looks like cancer, one of her test looked like her lungs were collapsing, she started feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks, had abnormal mammogram, abnormal CT scan, and abnormal PET scan. The patient's alkaline phosphatase level was 71 on Oct2020, 269 on 13May2021, and then 444 on 07Jul2021 and her doctor was concerned about these results. The events required physician's office visit for consultation. The patient underwent lab tests and procedures which included blood alkaline phosphatase: 71 on Oct2020, blood alkaline phosphatase: 269 on 13May2021, blood alkaline phosphatase: 444 on 07Jul2021, computerised tomogram: abnormal on 2021, test: lung were collapsing   on 2021, mammogram: normal on Jan2021 nothing was wrong, mammogram: abnormal on 2021, positron emission tomogram: abnormal on 2021. The patient has a biopsy scheduled for next week on her breast and lungs. The outcome of the event feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks was not recovered while for the rest of the events was unknown.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Positron emission tomogram, Positron emission tomogram abnormal
Clinical narrative: Alkaline Phosphatase Level 269/Alkaline Phosphatase Level 444; Started feeling bad, feeling not like herself/Felt like something was inside pushing or kneading for a couple of weeks; Abnormal Mammogram; Abnormal CT Scan; Abnormal PET Scan; Doctors saying it looks like cancer; Looks like lungs are collapsing; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 26Feb2021 as dose 2, single for covid-19 immunization at a hospital. Medical history included breast cancer from an unknown date and not ongoing recovered after radiation 6 years ago. There were no concomitant medications. No additional vaccines administered on the same day. No vaccinations within four weeks prior to the first administration date, states she does not normally get vaccines. The patient previously received the first dose of BNT162B2 on 05Feb2021 for COVID-19 immunization. On an unspecified date in 2021 after the last vaccination, the patient was having a lot of tests now and the doctors saying it looks like cancer, one of her test looked like her lungs were collapsing, she started feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks, had abnormal mammogram, abnormal CT scan, and abnormal PET scan. The patient's alkaline phosphatase level was 71 on Oct2020, 269 on 13May2021, and then 444 on 07Jul2021 and her doctor was concerned about these results. The events required physician's office visit for consultation. The patient underwent lab tests and procedures which included blood alkaline phosphatase: 71 on Oct2020, blood alkaline phosphatase: 269 on 13May2021, blood alkaline phosphatase: 444 on 07Jul2021, computerised tomogram: abnormal on 2021, test: lung were collapsing   on 2021, mammogram: normal on Jan2021 nothing was wrong, mammogram: abnormal on 2021, positron emission tomogram: abnormal on 2021. The patient has a biopsy scheduled for next week on her breast and lungs. The outcome of the event feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks was not recovered while for the rest of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Getting scalp on top of my head and that is like scab growing on my head; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Lot number was not reported), 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. Patient stated, I would like to speak about adverse event that I received, I had Covid Vaccine few months earlier I am getting scalp on top of my head, it is like scab that has grown. I don't know what is going on it's like "Anchil (not clarified the word) that is like scab growing on my head." Patient never had it before Covid vaccine. that is not approved and then I find a paper work, where I can do now, what am I supposed to do now. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis perforated, Cholecystitis infective
Clinical narrative: Appendix ruptured, after second vaccine.; Pain in her side, diagnosed as infected Gall Bladder, after second vaccine.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the upper left arm on 08Apr2021 at around 11:30 AM (Batch/Lot number was not reported) (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive additional vaccines on the same date of the Pfizer vaccine. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on 12Mar2021 at around 11:30 AM (Batch/Lot number was not reported) (at the age of 66-year-old) administered in the upper left arm for COVID-19 immunization. The patient was taking the Pfizer vaccine for COVID because she did not want to get sick and wanted to be around her family. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced appendix ruptured, after second vaccine on 28Apr2021 and at about 5AM, she went to the emergency room. She was admitted to the hospital. She has heard that other people have had ruptured appendix, after the vaccine. The patient experienced pain in her side, diagnosed as infected gall bladder, after second vaccine on 05May2021 05:00 AM. The patient reported that after she was released from the hospital, 2 days later, she was with pain in her side, diagnosed with an infected gall bladder, which was not removed. The patient reported that the pain in her side diagnosed as infected gall bladder occurred early in the morning maybe 5 AM. She was hospitalized for one night. She was admitted to the same hospital, both times. The events required a visit to emergency room and to physician office (after discharge from the hospital). The patient reported that there were no relevant tests. The outcome of appendix ruptured was recovered completely on 02May2021. The outcome of pain in her side diagnosed as infected gall bladder was recovered completely on 06May2021.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in 2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was sore on an unspecified date of 2021. The outcome of event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: after the second dose I had a fever and felt awful for a day; after the second dose I had a fever and felt awful for a day; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced after the second dose i had a fever and felt awful for a day on an unspecified date in 2021. It was reported that, patient had some issues with her second dose too. She got it when it first came out in Jan or Feb. (The caller thinks it was the Pfizer COVID-19 vaccine). After the first dose her arm was sore but then after the second dose she had a fever and felt awful for a day, then she was fine. The outcome of the event was unknown.  Information on Lot/Batch information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: I have got lot of eye issues; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0176), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were none. Patient did not have prior vaccination within four weeks. The patient reported that she could not get anything online to come up about side effects from the Pfizer vaccine. Three weeks after her second shot she had got lot of eye issues. She questioned if this was the problem with the vaccine having had a lot of problem, what is going on. She stated that she just had a new prescription last year and her eyes was awesome and now they were not awesome three weeks after having her second dose of Pfizer. Not yet but apparently, she was going to have it because of the vaccine. Therapeutic measures were not taken due to the event. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Malaise, Urticaria
Clinical narrative: Break down hives on my left wrist; I don't feel well; I am just disgusted at this point; This is a spontaneous report from a contactable consumer or other non-HCP.  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on Jun2021 as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization. Medical history included different allergies, allergy to plants, dust allergy, allergy to animal, food allergy as the patient was given contaminated food and water on purpose, helminthic infection as the patient have been sick for years for years with them, illness as the patient sick for years. The patient's concomitant medications were not reported.  on an unspecified date of 2021, the patient experienced break down hives on left wrist, don't feel well and was just disgusted at this point. The outcome of event break down hives on left was not recovered while outcome of rest all events was unknown.  Follow-up (04Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: menopause for a little over a year/menstrual like bleeding; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 at the age of 59 years old (Lot Number: EW0181; Expiration Date: Aug2021) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included hyperlipidaemia and menopause from an unknown date. Concomitant medication included rosuvastatin calcium (CRESTOR) taken for hyperlipidaemia from May2021 and ongoing. The patient had no other prior vaccination (Within four weeks). In Jul2021, the patient stated, "So, I am calling to report a potential side effects from the vaccine, So, I was vaccinated exactly one week ago on the 17Jul2021 and I am 59 years old and I have been out of menopause for a little over a year and today which is just one week after the vaccine actually started last night I had menstrual like bleeding, which is continue through today into this evening." The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling cold, Hypoaesthesia, Inappropriate schedule of product administration, Malaise
Clinical narrative: tingling in fingers; cold numb sensation in fingers; cold numb sensation in fingers; malaise; chest discomfort; severe sciatica like pain; received first dose on 10Mar2021 and second dose on 27Apr2021; This is a spontaneous report from a contactable consumer or other health care professional (Patient).   A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8732, Expiration date: Unknown), via an unspecified route of administration, in Left Arm on 27Apr2021 (at the age of 40-years-old) as DOSE 2, SINGLE for Covid-19 immunisation at School or Student Health Clinic. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient received concomitant medications within 2 weeks included ibuprofen (ADVIL [IBUPROFEN]), ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot/Batch: EN6199, Expiration date: Unknown), via an unspecified route of administration in Left Arm on 10Mar2021 (at the age of 40-years-old) as dose 1, single for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date Approx 6-7 weeks after second vaccine: tingling in fingers, cold numb sensation in fingers, malaise, chest discomfort, followed by severe sciatica like pain for 2-3 days in right leg. I do not typically develop sciatica like pain (last experienced during pregnancy over 5 years ago), The patient received first dose on 10Mar2021 and second dose on 27Apr2021. Therapeutic measures were taken as a result of tingling in fingers, cold numb sensation in fingers, cold numb sensation in fingers, malaise, chest discomfort, severe sciatica like pain. The treatment received for the events which included Ibuprofen and gabapentin to help with pain. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events was recovered on unspecified date of 2021.   Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sciatica
Clinical narrative: tingling in fingers; cold numb sensation in fingers; cold numb sensation in fingers; malaise; chest discomfort; severe sciatica like pain; received first dose on 10Mar2021 and second dose on 27Apr2021; This is a spontaneous report from a contactable consumer or other health care professional (Patient).   A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8732, Expiration date: Unknown), via an unspecified route of administration, in Left Arm on 27Apr2021 (at the age of 40-years-old) as DOSE 2, SINGLE for Covid-19 immunisation at School or Student Health Clinic. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient received concomitant medications within 2 weeks included ibuprofen (ADVIL [IBUPROFEN]), ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot/Batch: EN6199, Expiration date: Unknown), via an unspecified route of administration in Left Arm on 10Mar2021 (at the age of 40-years-old) as dose 1, single for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date Approx 6-7 weeks after second vaccine: tingling in fingers, cold numb sensation in fingers, malaise, chest discomfort, followed by severe sciatica like pain for 2-3 days in right leg. I do not typically develop sciatica like pain (last experienced during pregnancy over 5 years ago), The patient received first dose on 10Mar2021 and second dose on 27Apr2021. Therapeutic measures were taken as a result of tingling in fingers, cold numb sensation in fingers, cold numb sensation in fingers, malaise, chest discomfort, severe sciatica like pain. The treatment received for the events which included Ibuprofen and gabapentin to help with pain. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events was recovered on unspecified date of 2021.   Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal
Clinical narrative: this is my eight day since I got the vaccine and I just been flat on my back, I am like, feel like crap; I have been dizzy and I had a fatigue, exhausted just flat on my back; I have been dizzy and I had a fatigue, exhausted just flat on my back; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jul2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient stated that this is eight day since patient got the vaccine and patient was just been flat on back, patient feel like crap, dizzy and had a fatigue, exhausted just flat on back. Patient feel like crap for 9 days it's been be 9 days tomorrow. Why so long it said only couple of days you know and I lost a whole week. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Induration, Papule
Clinical narrative: lumps all over my body/breaking out all over; lumps all over my body/breaking out all over; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient getting side effect from this thing, breaking out all over. It was also reported that started getting lumps all over body. When probed if consumer have some medical information about the same, patient stated, "Yes. The outcome for the event was reported as unknown at the time of this report.   Information about lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Vulnerable; This is a spontaneous report from a contactable consumer (patient's daughter) or other non hcp. A 73-years-old male patient (Reporter's father) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 2021 as DOSE 2, SINGLE for covid-19 immunisation (It is about 6 months now after his second Pfizer Covid vaccination). Medical history included diabetes mellitus and heart attack (the patient has diabetes and had suffered a heart attack prior to his Covid vaccination). The patient's concomitant medications were not reported. The patient received dose 1 of bnt162b2 on an unknown date for covid-19 immunisation. The patient experienced vulnerable on an unknown date in 2021. The reporter want to enroll the patient in the Covid booster trial. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Investigation, Pain in extremity, Ultrasound scan
Clinical narrative: bilateral leg pain from his hips all the way down; bilateral leg pain from his hips all the way down; This is a spontaneous report from a contactable pharmacist (patient's wife). A 59-years-old male patient (reporter's husband) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 18Apr2021 (Lot number and Expiry date was not reported) as dose 2, single for COVID-19 immunization. The patient's and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 26Mar2021 for COVID-19 immunization. It was reported that towards the end of Jun2021, the patient started complaining of bilateral leg pain from his hips all the way down. The patient went to an urgent care. He went to the family physician and they ordered an ultrasound to check for deep vein thrombosis and abdominal aneurysm and it was negative. The pain was not going away and it was very severe. They ordered bloodwork on an unknown date and tested lyme disease but it was negative. The pain took 2 weeks to go away. The patient had to take Tylenol and Advil around the clock spaced out for two weeks. The reporter believed that it is related to the Pfizer Covid vaccine. This was out of character for the patient. They have not been able to diagnose it. This happened after the second shot. The leg pain went away on Jul2021 (reported as 'around 10Jul2021'). The patient recovered but did not specify if completely or with lasting effects. The patient had other inflammatory markers done that came back negative. The events were reported with a seriousness of disability. The events recovered on an unknown date in Jul2021.   Information about Lot/batch number has been requested; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.