chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Autoimmune hepatitis, Biopsy liver, Conjunctivitis, Drug-induced liver injury
Clinical narrative: auto immune hepatitis; drug induced liver injury; Primary Delivery Conjunctivitis; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program.  A 40-year-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/Lot number and Expiration date were unknown), via an unspecified route of administration, on an unspecified date (at the age of 40-years-old), as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient was taking an unspecified medication for 2-months which she stopped before. It was reported that on an unspecified date, the patient had an increased INR, ALT and liver enzymes elevated along with jaundice, and Hepatitis. Patient was admitted to hospital for Hepatitis. The elevation of the liver enzymes reached to a point that she needed the liver biopsy which was more challenging to interpret. Then sent out at 7 PM to her medical surgery and they had reported neuropathologist, so they were saying that her Jaundice elevated function test and overwhelmed drug reaction. As per the expert pathologist report, the patient had only the drug (unspecified medication) that she had been on that for 2 months which she stopped before and she did have "elevated intestinal muscle antibody" (not clarified) but she was not consisting auto immune hepatitis, however, the serology suggested an auto immune hepatitis but the biopsy could not and then the liver biopsy shows patient has "Primary Delivery Conjunctivitis" (further not clarified) but the serology is not consisting with that, so the reporter stated that her concern was that mimicking this disease process. Pathologist said that it was a drug induced liver injury. The reporter stated that their doctor reporting that several patients after taking of Covid vaccine has had elevated liver function test and even had one that needed the liver biopsy, and he was asking if this was something that happening with the Covid vaccine or what are the study showing. The patient underwent lab tests and procedures which included: Liver Biopsy: Primary Delivery Conjunctivitis; INR (International normalised ratio): elevated; Liver function test: elevated; aminotransferase: elevated; antibody test: elevated intestinal muscle (not clarified); all tests on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Liver function test, Transaminases
Clinical narrative: auto immune hepatitis; drug induced liver injury; Primary Delivery Conjunctivitis; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program.  A 40-year-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/Lot number and Expiration date were unknown), via an unspecified route of administration, on an unspecified date (at the age of 40-years-old), as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient was taking an unspecified medication for 2-months which she stopped before. It was reported that on an unspecified date, the patient had an increased INR, ALT and liver enzymes elevated along with jaundice, and Hepatitis. Patient was admitted to hospital for Hepatitis. The elevation of the liver enzymes reached to a point that she needed the liver biopsy which was more challenging to interpret. Then sent out at 7 PM to her medical surgery and they had reported neuropathologist, so they were saying that her Jaundice elevated function test and overwhelmed drug reaction. As per the expert pathologist report, the patient had only the drug (unspecified medication) that she had been on that for 2 months which she stopped before and she did have "elevated intestinal muscle antibody" (not clarified) but she was not consisting auto immune hepatitis, however, the serology suggested an auto immune hepatitis but the biopsy could not and then the liver biopsy shows patient has "Primary Delivery Conjunctivitis" (further not clarified) but the serology is not consisting with that, so the reporter stated that her concern was that mimicking this disease process. Pathologist said that it was a drug induced liver injury. The reporter stated that their doctor reporting that several patients after taking of Covid vaccine has had elevated liver function test and even had one that needed the liver biopsy, and he was asking if this was something that happening with the Covid vaccine or what are the study showing. The patient underwent lab tests and procedures which included: Liver Biopsy: Primary Delivery Conjunctivitis; INR (International normalised ratio): elevated; Liver function test: elevated; aminotransferase: elevated; antibody test: elevated intestinal muscle (not clarified); all tests on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: he also was like paralyzed like caller was; This is a spontaneous report form a contactable consumer. This is report 3 of 5. A male patient of an unspecified age 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 on an unspecified date at dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. On an unspecified date, the patient experienced he also was like paralyzed like caller was. Consumer reported for patient stating that: reporter's girlfriends cousin's housemate, her ex-husband is patient. Patient got the Pfizer Covid vaccine and he had basically the same symptoms that reporter did; but patient went for his second shot and felt good for 24 hours like he did on first shot; but patient also was like paralyzed like reporter was. The clinical outcome of the he also was like paralyzed like caller was unknown.  Follow up attempts are needed. Further information has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Loss of consciousness
Clinical narrative: passed out for 20-30 min 2 days after receiving covid vaccine; headache; fatigue; This is a spontaneous report from a contactable nurse. A 15-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0180), via an intramuscular route administration on 18Jun2021 (at the age of 15years) in right arm as DOSE 1, SINGLE for covid-19 immunization. Vaccine was administered at pharmacy or drug store. No medical history was reported. Patient had no known allergies. Concomitant medications included celecoxib (CELEXA) used for an unspecified indication. Patient was not diagnosed with COVID-19 prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On 20Jun2021, the patient passed out for 20-30 min 2 days after receiving COVID vaccine and had headache and fatigue. Patient visited Doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. The patient had not taken any treatment for reported events. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Polymerase chain reaction
Clinical narrative: Started developing joint pains and swelling. Multiple joints and painful swollen joints.; Started developing joint pains and swelling. Multiple joints and painful swollen joints.; This is a spontaneous report from a contactable physician (patient). A 40-years-old non pregnant female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EH9899, expiration date unspecified), via an unspecified route of ad-ministration, administered in Arm Left on 17Dec2020 as dose 2, single dose for covid-19 immunization at Hospital. Previously the patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EH9899, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on an unknown date as dose 1, single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported, minocycline taken for an unspecified indication,start and stop date were not reported, ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 16:00, the patient started developing joint pains and swelling, multiple joints and painful swollen joints. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient had Nasal swab PCR (polymerase chain reaction test) and results were negative on 22Mar2021. Again, the patient had Nasal Swab (PCR) on 09Apr2021, and results were negative. The patient was treated with Naproxen, steroids, sulfasalazine for the events. The outcome of the events was reported as not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the events arthralgia, joint swelling and the suspect drug cannot be excluded. 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: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Illness, Pruritus, Swelling face
Clinical narrative: Face swells up; Turns really red and itching; Face swells up and turns really red and itching; Really sick the day after she got her second dose; This is a spontaneous report from a contactable consumer (patients mother). A 14-years-old female patient received bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 12Jun2021 (at the age of 14-years-old) as dose 2, single for COVID-19 immunisation. Medical history included asthma. There were no concomitant medications. The patient previously took BNT162B2 as first dose on 05May2021 or 06May2021(NDC, Expiration Date, Lot: Unknown) administered in left upper arm. On an unspecified date, the patient experienced face swells up, turns really red and itching, face swells up and turns really red and itching, really sick the day after she got her second dose. Patients mother stated she had to take the patient to the emergency room first time this happened, this was already the third time it was happening again and stated the patients face was swelled up and turned really red and itching. Patient mother added it looked like an allergic reaction, but she thought it was not an actual allergic reaction from what she read, she guessed it was her body trying to fight off this and the patient was really sick the day after she received her second dose and thought it was just going to end there with that, as she seemed to be ok for a week or two, and now yesterday and the patients mother gave another Benadryl, because the patient said, the same thing was happening to her face. Patients mother stated that she was calling to report about her daughter has been going though since she had been vaccinated, the patient having adverse reactions and confirms the product was the COVID vaccine and stated she had only a few minutes to go through the report, she was at work, when queried by agent. Therapeutic measures were taken as a result of face swells up, turns really red and itching, face swells up and turns really red and itching. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pneumonia staphylococcal
Clinical narrative: He indicates he experiences shortness of breath following MRSA pneumonia.; He indicates he experiences shortness of breath following MRSA pneumonia.; Caller started coughing on the phone; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number and Expiry date: not reported), via an unspecified route of administration on 24Jun2021 as dose 2, single for covid-19 immunisation. Medical history included covid-19 (he thinks a few months ago he had SARs-COV-2), and had allergies from "heck" this year. The patient's concomitant medications were not reported. Previously patient received first dose of bnt162b2 (Lot number Not reported), on an unknown date for covid-19 immunization and he fell backwards and was intubated (tube in his throat) and stayed in the hospital for fourteen days. On an unknown date in Jun 2021, the patient experienced shortness of breath following MRSA pneumonia. And he started coughing on the phone. The patient wanted to know when the 95% efficacy starts and how to count the seven days. He states that he heard on the news that he should still wear a mask, so he will wait till the seven days and continue to wear a mask as he had been in hospital three times this year. The outcome of the events was unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a non-contactable consumer (mother) reported for a patient (her daughter) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date was not reported) first dose via an unspecified route of administration on 24Jun2021 single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Mother of the patient (who did not introduce herself) called for her daughter, withheld, who got the first dose of the Pfizer Covid-19 vaccine on 24Jun2021 and would like to know if patient can take either Tylenol or Ibuprofen for the slight headache she was experiencing after the shot. The outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Insomnia, Nausea
Clinical narrative: severe nausea; headache; dizziness; cant sleep; This is a spontaneous report from a contactable consumer (Parent). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 23Jun2021 at 10:00 (at the age of 13-year-old), as dose 2, single in right arm, for COVID-19 immunization at Urgent Care Center. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization. On 23Jun2021, several hours after the vaccine, the patient experienced severe nausea, a headache and dizziness. Patient also reported that she couldn't sleep, even after taking Advil pm. Reporter, stated they did not sought treatment but may if that continues or worsens. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Insomnia, Nausea
Clinical narrative: Severe nausea; Headache; Dizziness; Can't sleep; This is a spontaneous report from a contactable consumer (parent). A 13-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiry date: not reported, age at vaccination: 13-year-old), via an unspecified route of administration, in Arm Right on 23Jun2021 10:00 AM as dose 2, single for covid-19 immunisation administered in Doctor's office/urgent care. The patient medical history and concomitant medications were not reported. Previously, the patient received first dose of bnt162b2 (Lot number not reported), on an unspecified date for covid-19 immunization (age at the time of vaccination: 13-year-old). On 23 Jun2021, several hours after the vaccine, the patient complained of sever nausea, a headache and dizziness. She also cannot sleep, even after taking Advil pm. The treatment was not yet sought but may if this continues or worsens. The patient visited doctor or other healthcare professional office or clinic visit due to these adverse events. The patient did not receive any other vaccines within 4 weeks prior to covid vaccine and did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior or since the vaccination. The outcome of event was not recovered.  Information on the lot/ batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Insomnia, Nausea
Clinical narrative: Severe nausea; Severe headache; Dizziness; can't sleep; This is a spontaneous report from a contactable consumer (parent reporting for daughter). A 16-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 23Jun2021 10:00 as dose 2, single (at the age of 16-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks, prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient medical history included depression and exercise asthma. Patient had no known allergies. The concomitant medications included lithium, venlafaxine hydrochloride (EFFEXOR), mirtazapine. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm as dose 1, single for COVID-19 immunization. On 23Jun2021, several hours after the vaccine she was complaining of severe nausea, headache and dizziness. She also reported she could not sleep, even after taking Advil pm. We have not yet sought treatment but may if this continues or worsens. 3 of the 4 of her kids were reporting similar symptoms although 2 are effected much more. The reported case seriousness was non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Mother was unsure if they will go to the ER or urgent care. It was unknown if any treatment was received for the events nausea, dizziness and headache. The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Full blood count, Glomerular filtration rate, Metabolic function test, Ocular hyperaemia
Clinical narrative: left arm was numb; face has swollen big time; Eyes immediately becomes red; Left arm was painful; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171, Expiry date was not reported), via intramuscular route of administration, administered in left arm on 21Jun2021 (at the age of 59-year-old), as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Jun2021 to Jun2021. The patient's concomitant medications were not reported. It was reported that patient got one problem, he test positive for the COVID (Intent: history). Patient waited 10 days. He went to test it again and he tested negative (Further clarification was unknown). The following day (Clarification unknown) he went and got the vaccine, Pfizer first dose that was last Monday, he think 21st and my eyes immediately becomes red. he got home, he stayed home, the following day my left arm was painful but he did not worry much because they told me that will be normal but he went to work Wednesday and he was just working and my left arm was numb and my face has swollen big time and that was numb so he went to the emergency room, they did the test, everything was good so, that is my concern. Yes patient went to the emergency at '9o'clock'. That was in the Baptist hospital, they say everything was good. That was the hospital. You have to call them I do not know. He have given you the information, from there you can call them and find out because he do not know how to read these numbers. The patient was 9095 (incomplete sentence). That was why you have to call. he do not know how to read this thing, Here it says test performed, they did the test on glomerular filtration rate, metabolic panel, BMP, CBC, 'BFT' and 'troponin', Everything was good. FT4, FT3, 'TPO'. (Not appropriately clarified hence not captured in tab). Patient want to report it because he want to see (incomplete sentence) he do not know if he should get the second one and ends with the same thing, get sick. he do not know if he should not try to go to work. The patient underwent lab tests and procedures which included anti-thyroid antibody: unknown, full blood count: good, glomerular filtration rate: good, metabolic function test: good, metabolic function test: good, thyroxine free: unknown, tri-iodothyronine free: unknown, troponin: good all on 23Jun2021 and sars-cov-2 test: positive on Jun2021 and sars-cov-2 test: negative on 20Jun2021. The outcome of the events left arm was numb, face has swollen big time, eyes immediately becomes red, left arm was painful was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling face, Thyroxine free, Tri-iodothyronine free, Troponin
Clinical narrative: left arm was numb; face has swollen big time; Eyes immediately becomes red; Left arm was painful; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171, Expiry date was not reported), via intramuscular route of administration, administered in left arm on 21Jun2021 (at the age of 59-year-old), as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Jun2021 to Jun2021. The patient's concomitant medications were not reported. It was reported that patient got one problem, he test positive for the COVID (Intent: history). Patient waited 10 days. He went to test it again and he tested negative (Further clarification was unknown). The following day (Clarification unknown) he went and got the vaccine, Pfizer first dose that was last Monday, he think 21st and my eyes immediately becomes red. he got home, he stayed home, the following day my left arm was painful but he did not worry much because they told me that will be normal but he went to work Wednesday and he was just working and my left arm was numb and my face has swollen big time and that was numb so he went to the emergency room, they did the test, everything was good so, that is my concern. Yes patient went to the emergency at '9o'clock'. That was in the Baptist hospital, they say everything was good. That was the hospital. You have to call them I do not know. He have given you the information, from there you can call them and find out because he do not know how to read these numbers. The patient was 9095 (incomplete sentence). That was why you have to call. he do not know how to read this thing, Here it says test performed, they did the test on glomerular filtration rate, metabolic panel, BMP, CBC, 'BFT' and 'troponin', Everything was good. FT4, FT3, 'TPO'. (Not appropriately clarified hence not captured in tab). Patient want to report it because he want to see (incomplete sentence) he do not know if he should get the second one and ends with the same thing, get sick. he do not know if he should not try to go to work. The patient underwent lab tests and procedures which included anti-thyroid antibody: unknown, full blood count: good, glomerular filtration rate: good, metabolic function test: good, metabolic function test: good, thyroxine free: unknown, tri-iodothyronine free: unknown, troponin: good all on 23Jun2021 and sars-cov-2 test: positive on Jun2021 and sars-cov-2 test: negative on 20Jun2021. The outcome of the events left arm was numb, face has swollen big time, eyes immediately becomes red, left arm was painful was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia, Vaccination site pain
Clinical narrative: left arm was numb; face has swollen big time; Eyes immediately becomes red; Left arm was painful; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171, Expiry date was not reported), via intramuscular route of administration, administered in left arm on 21Jun2021 (at the age of 59-year-old), as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Jun2021 to Jun2021. The patient's concomitant medications were not reported. It was reported that patient got one problem, he test positive for the COVID (Intent: history). Patient waited 10 days. He went to test it again and he tested negative (Further clarification was unknown). The following day (Clarification unknown) he went and got the vaccine, Pfizer first dose that was last Monday, he think 21st and my eyes immediately becomes red. he got home, he stayed home, the following day my left arm was painful but he did not worry much because they told me that will be normal but he went to work Wednesday and he was just working and my left arm was numb and my face has swollen big time and that was numb so he went to the emergency room, they did the test, everything was good so, that is my concern. Yes patient went to the emergency at '9o'clock'. That was in the Baptist hospital, they say everything was good. That was the hospital. You have to call them I do not know. He have given you the information, from there you can call them and find out because he do not know how to read these numbers. The patient was 9095 (incomplete sentence). That was why you have to call. he do not know how to read this thing, Here it says test performed, they did the test on glomerular filtration rate, metabolic panel, BMP, CBC, 'BFT' and 'troponin', Everything was good. FT4, FT3, 'TPO'. (Not appropriately clarified hence not captured in tab). Patient want to report it because he want to see (incomplete sentence) he do not know if he should get the second one and ends with the same thing, get sick. he do not know if he should not try to go to work. The patient underwent lab tests and procedures which included anti-thyroid antibody: unknown, full blood count: good, glomerular filtration rate: good, metabolic function test: good, metabolic function test: good, thyroxine free: unknown, tri-iodothyronine free: unknown, troponin: good all on 23Jun2021 and sars-cov-2 test: positive on Jun2021 and sars-cov-2 test: negative on 20Jun2021. The outcome of the events left arm was numb, face has swollen big time, eyes immediately becomes red, left arm was painful was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: heart pain consistent for about a week after 2nd dose and now the heart pain comes and goes with certain activity.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 22Apr2021 (Batch/Lot Number: EW0170) as DOSE 1, SINGLE for covid-19 immunization). Medical history included coeliac disease, autoimmune disorder and gluten allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. On 23Apr2021 the patient experienced heart pain consistent for about a week after 2nd dose and now the heart pain comes and goes with certain activity. The adverse event resulted in emergency room/department or urgent care. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Myalgia, Petechiae, Pruritus, Rash erythematous
Clinical narrative: Itchiness on hands; Muscle aches (mostly hips and legs); Worsening eczema; Trunk rash (around 30 itchy red spots); Trunk rash (around 30 itchy red spots); Petechiae on shins; This is a spontaneous report from a contactable consumer (patient herself). A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0168 and expiration date was not reported), via an unspecified route of administration in left arm on 11May2021 10:30 as 1st dose, single (age at vaccination was 34-year-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included ongoing Eczema, Raynaud's, ANA-positive. The patient concomitant medication was not provided. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In May 2021 09:00 patient experienced Trunk rash (around 30 itchy red spots), Muscle aches (mostly hips and legs), Worsening eczema and itchiness on hands, Petechiae on shins. The patient was not taking any treatment. The outcome of all event was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchiness on hands; Muscle aches (mostly hips and legs); Worsening eczema; Trunk rash (around 30 itchy red spots); Trunk rash (around 30 itchy red spots); Petechiae on shins; This is a spontaneous report from a contactable consumer (patient herself). A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0168 and expiration date was not reported), via an unspecified route of administration in left arm on 11May2021 10:30 as 1st dose, single (age at vaccination was 34-year-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included ongoing Eczema, Raynaud's, ANA-positive. The patient concomitant medication was not provided. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In May 2021 09:00 patient experienced Trunk rash (around 30 itchy red spots), Muscle aches (mostly hips and legs), Worsening eczema and itchiness on hands, Petechiae on shins. The patient was not taking any treatment. The outcome of all event was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Asthenia, Erythema, Fatigue, Fibromyalgia
Clinical narrative: had tiny pimples in my arms, chest; reddish color on my face; rashes; general malaise associated with fibro is increasing; weak; puked; general malaise associated with fibro is increasing; fatigue is worsening/feel totally drained; can't even walk without feeling the necessity to rest; have a headache that feels like something is pumping in my brain; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0168), via an unspecified route of administration in right arm on 14Jun2021 at 12:00 as (at the age of 46 years old) single for covid-19 immunisation. Medical history included fibromyalgia, don't have a thyroid and have high blood pressure. The patient had allergic/not common side-effects to around 30 medicines, food allergies, dust and other allergies. Concomitant medications that patient received within 2 weeks of vaccination included levothyroxine sodium (EUTHYROX), 75 microgram, lisinopril 7.5g total, others. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 14Jun2021, at 12:15, 15 minutes after of receiving the first dosage, she had tiny pimples in her arms, chest and reddish color on her face. This kind of allergic reaction she had in the past and normally develops in short breath and other symptoms. At that point she took 2 pills of desloratadine 5 mg. Since then (today is 24Jun) fatigue is worsening. She can't even walk without feeling the necessity to rest. She also feels totally drained after eating, her rashes come and go during the day and general malaise associated with fibro is increasing. She feels very weak. Since last night she has a headache that feels like something is pumping in her brain. Today she puked. She is asking how long these symptoms will last. The adverse event resulted: Doctor or other healthcare professional office/clinic visit. The patient received treatment due to the had tiny pimples in my arms, chest, reddish color on my face and general malaise associated with fibro is increasing. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Malaise, Rash, Vomiting
Clinical narrative: had tiny pimples in my arms, chest; reddish color on my face; rashes; general malaise associated with fibro is increasing; weak; puked; general malaise associated with fibro is increasing; fatigue is worsening/feel totally drained; can't even walk without feeling the necessity to rest; have a headache that feels like something is pumping in my brain; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0168), via an unspecified route of administration in right arm on 14Jun2021 at 12:00 as (at the age of 46 years old) single for covid-19 immunisation. Medical history included fibromyalgia, don't have a thyroid and have high blood pressure. The patient had allergic/not common side-effects to around 30 medicines, food allergies, dust and other allergies. Concomitant medications that patient received within 2 weeks of vaccination included levothyroxine sodium (EUTHYROX), 75 microgram, lisinopril 7.5g total, others. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 14Jun2021, at 12:15, 15 minutes after of receiving the first dosage, she had tiny pimples in her arms, chest and reddish color on her face. This kind of allergic reaction she had in the past and normally develops in short breath and other symptoms. At that point she took 2 pills of desloratadine 5 mg. Since then (today is 24Jun) fatigue is worsening. She can't even walk without feeling the necessity to rest. She also feels totally drained after eating, her rashes come and go during the day and general malaise associated with fibro is increasing. She feels very weak. Since last night she has a headache that feels like something is pumping in her brain. Today she puked. She is asking how long these symptoms will last. The adverse event resulted: Doctor or other healthcare professional office/clinic visit. The patient received treatment due to the had tiny pimples in my arms, chest, reddish color on my face and general malaise associated with fibro is increasing. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass
Clinical narrative: lump under my neck; I think it's like swollen lymph node; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on Jun2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she received the vaccine about a week ago, and the fifth day, she had a lump under her neck. She thinks it's like swollen lymph node on unspecified date of Jun2021. The outcome of the events was unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstruation delayed
Clinical narrative: hasn't had her period in almost 3 months; hasn't had her period in almost 3 months; This is a spontaneous report from a contactable consumer or other non hcp (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on 01May2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, received PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. This report was related to a study or programme. On an unspecified date, the patient experienced "she hasn't had her period in almost 3 months." The patient wanted to know if that was a normal side effect. She had also stopped breast feeding. Seriousness of the events were provided as unspecified by reporter. NDC number of PFIZER COVID 19 vaccine was not provided. Investigation assessment was not provided. Outcome of the events was unknown. Information on the lot/batch number has been requested
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Wheezing
Clinical narrative: Felt like a board in her chest; Trouble Breathing; Coughing and Couldn't Quit; Wheezing a bit when she breathed in; This is a spontaneous report received from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6206, Expiry Date: Unknown), via an unspecified route of administration, in the left arm on 11Mar2021 11:00 as dose 1, single for covid-19 immunisation. Medical history included asthma from 2014 and ongoing, under control as long as she did not eat anything that triggers it. Family medical history included patient mother would have severe reactions to everything and it got worse the older she got. The patient's concomitant medications were not reported. No history of all previous immunization with the pfizer vaccine considered as suspect. No additional vaccines administered on same date of the pfizer suspect. The patient did not received any vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced a reaction that felt like a board in her chest, trouble breathing, and wheezing. Appointment was at 11:00, so shot at 11:30, home by noon, started within 15 minutes of that, so about 12:15 to 12:30 pm. Caller stated her reaction started an hour after she got back home. Caller stated it first felt like a board in her chest and then she started coughing and couldn't quit. Then she noticed she was beginning to wheeze a bit when she breathed in. She had a similar reaction with wheezing when she has had a shot of Penicillin or Sulfa medications in the past, so she thought, oh gosh, she was having an allergic reaction, so she took Benadryl and it worked. Caller stated she was too scared to take the second one. Caller stated the reaction stopped within 20 minutes of taking the Benadryl. She did take a flu vaccine back in 2005 and she didn't have a reaction. Caller reported she did not have a primary care doctor anymore as he recently died. Caller has not yet received the second dose of the vaccine due to CDC website recommendation to not take second vaccine after experiencing wheezing with the first. Patient had received treatment for event was Benadryl. Adverse event did not require a visit to emergency room or physician office. Outcome of all events was recovered on 11Mar2021.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bloody discharge, Tumour inflammation
Clinical narrative: cause my tumor in my right armpit and right breast to be inflamed; discharge with blood; This is a spontaneous report from a contactable other hcp via Pfizer sponsored program. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 58-year-old) as dose number unknown single for covid-19 immunisation; palbociclib (IBRANCE), via oral route from 03May2021 (Batch/Lot number was not reported) and ongoing, at 75 mg, daily for 21 days of 28-day cycle for breast cancer. The patient's medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unknown date, the patient had tumour in right armpit and right breast to be inflamed and discharge with blood. The patient reported that noticed the mass was shrinking in right armpit. The covid vaccine caused tumour in right armpit and right breast to be inflamed and have more discharge with blood. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known safety  profile and available information the reported  events tumour inflammation and bloody discharge are assessed as unrelated to BNT162B2.  These events may be due to the current medical history of breast cancer which is ongoing and under treatment. Case will be reassessed if additional information is received.
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Biopsy bladder, Blood disorder, Computerised tomogram, Loss of personal independence in daily activities
Clinical narrative: Blood clots; vaccine is attacking her kidneys; Lost 20 pounds; The blood looks like merlot wine; The blood looks like merlot wine. This is painful; Mentally distraught; I have lost 20 pounds and cannot work.; This is a spontaneous report from a contactable consumer (patient reported for herself). A 41-years-old female patient received her second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 27Mar2021, as single for covid-19 immunisation. Medical history included Bladder biopsy and hysterectomy in 2016. The patient concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 06Mar2021, as single for covid-19 immunisation and between 06Mar- 13Mar2021, she had all the side effects: night sweats, colds, nauseated, sore arm, fever, I was sick. On 18Mar, she began urinating blood and was not stopped. On an unspecified date in Mar2021, after the second dose the patient experienced blood clots and the vaccine is attacking her kidneys, lost 20 pounds and cannot work, the blood looks like merlot wine and mentally distraught. The clinical course of the events as follows: She went to the emergency room, when the blood first started. She stated that the vaccine was attacking her kidneys and they did not know why. On an unspecified date in Jan2021, she got a clean bill of health at her annual checkup. She had a hysterectomy in 2016, so this was not vaginal bleeding. She had passing blood clots at this point and this was painful. She mentioned, no one was able to figure out what the vaccine was doing to her. She had seen a nephrologist, a urologist and her primary care physician for the events. She had an appointment with a clinic scheduled. She stated she had lost 20 pounds and could not work. She stated that her blood looks like merlot wine and she was mentally distraught. Her MD said he had read about this in a journal about other patients. She had been to 4 different hospitals, had 3 CAT (computerized tomography) scans for which the result was unknown. She has had x-rays and was in and out of the emergency room. On an unspecified date, the patient underwent lab tests biopsy bladder: unknown, computerized tomogram: unknown, x-ray: unknown. She had her blood drawn every 2 weeks. The outcome of the events was unknown at the time of this report. The patient was Referred to HCP and provided info on the countermeasures Injury Compensation Program  Information on the lot/batch number has been requested.