chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac monitoring abnormal, Carditis, Echocardiogram abnormal, Palpitations
Clinical narrative: Since the second vaccine, I have noted palpitations, heart inflammation and afib.  Previously I have never experienced any health problems related to my heart. I have also taken an extensive physical every year including treadmill stress tests that have shown healthy heart. These symptoms are almost a daily occurance now and I am currently seeking treatment for these problems.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Catheterisation cardiac, Chest discomfort, Chest pain, Dyspepsia
Clinical narrative: Chest tightness, heart burn and elevated BP/heart rate
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Troponin increased
Clinical narrative: Chest tightness, heart burn and elevated BP/heart rate
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Sharp lower back pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for COVID-19 > 14 days after Pfizer vaccine series
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Crying, Depression, Feeling abnormal, Feelings of worthlessness, Hyperacusis
Clinical narrative: Depression - does not want to get out of bed, has been crying frequently, feelings of worthlessness. All very unlike his normal self Migraines: severe light sensitivity, noise sensitivity, touch sensitivity, nausea.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Migraine, Nausea, Photophobia
Clinical narrative: Depression - does not want to get out of bed, has been crying frequently, feelings of worthlessness. All very unlike his normal self Migraines: severe light sensitivity, noise sensitivity, touch sensitivity, nausea.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Myalgia, Tremor
Clinical narrative: Severe shakes Severe shortness of breath joint/muscle pain
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Blood test normal, Differential white blood cell count normal, Full blood count normal, Gait disturbance
Clinical narrative: Right hip pain without history of injury. Not able to walk starting 10/2 and 10/3. X-ray and lab test ruled out other causes. Diagnosed as Toxic Synovitis based on symptoms. Pain subsided 10/4.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test normal, Red blood cell sedimentation rate normal, Synovitis, X-ray of pelvis and hip normal
Clinical narrative: Right hip pain without history of injury. Not able to walk starting 10/2 and 10/3. X-ray and lab test ruled out other causes. Diagnosed as Toxic Synovitis based on symptoms. Pain subsided 10/4.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: I have Morderna COVID 19 vaccin
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Echocardiogram, Ejection fraction decreased, Feeling abnormal
Clinical narrative: Heart Failure Ejection factor dropped to 24%. Down from 44% . Like I fell off of a cliff. Not a slow decline.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Panic attack
Clinical narrative: Chronic Fatigue, Physical Panic attacks, but mind is clear, only physical response
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Hyperhidrosis, Pyrexia, Sleep disorder
Clinical narrative: Fever,  chills, sweating, didn't sleep well, about 20 hrs total
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anal rash, Burning sensation, Chest pain, Gastrooesophageal reflux disease
Clinical narrative: Rash on right part of the anus. Severe acid reflux, burning and consistent chest pain.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Five days after receiving my Pfizer booster, I developed a herpes zoster lesion on my left upper arm  approximately the size of a silver dollar; symptoms of itching, redness, swelling, and blisters.   I applied acyclovir ointment 5% topically and it is slowly getting better.  This has been a chronic site of herpes zoster in the past and usually only erupts about once per year.  This lesion has now erupted after my first, second, and third dose of Pfizer so know that there must be a connection to the Pfizer vaccine.  Also, this third dose reaction appears worse in size and intensity even though I have received both doses of Shingrix in 2019.  I would like to know what the health implications are?  Is the Pfizer vaccine making my Shingrix vaccine null and void?  Do I need to get vaccinated again with Shingrix?  How is this affecting my immunity against Covid-19?  Is my body able to produce antibodies against Covid-19 as it is supposed to do?
Age: 21.0
Sex: F
Vaccine: FLUA4
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Hives, sweating, high fever, swelling, redness, pain, nausea, extreme fatigue, cramping, diarrhea, headache
Age: 21.0
Sex: F
Vaccine: FLUA4
Symptoms: Muscle spasms, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Hives, sweating, high fever, swelling, redness, pain, nausea, extreme fatigue, cramping, diarrhea, headache
Age: 21.0
Sex: F
Vaccine: FLUA4
Symptoms: Urticaria
Clinical narrative: Hives, sweating, high fever, swelling, redness, pain, nausea, extreme fatigue, cramping, diarrhea, headache
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Patient fully vaccinated and died due to Covid related causes
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inflammation, Pain, Pyrexia
Clinical narrative: 12 hours after the second MODERNA application, I had chills for 6 hours, later I had fever, head pain. I vomited some clear green phlegm. After vomiting I felt a lot better but with some body pain but it went away the next day. I feel good now but after having chills, I feel chest inflammation on the left side and I still have that symptom.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Sputum discoloured, Vomiting
Clinical narrative: 12 hours after the second MODERNA application, I had chills for 6 hours, later I had fever, head pain. I vomited some clear green phlegm. After vomiting I felt a lot better but with some body pain but it went away the next day. I feel good now but after having chills, I feel chest inflammation on the left side and I still have that symptom.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizzy even when lying down. Intermittent vertigo sensations.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Patient fully vaccinated and hospitalized. Died about 20 days later due to Covid related causes
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Impaired work ability
Clinical narrative: 10/5/2021: chills, soreness injection site, headache, fatigue (12am) 6am: severe fatigue chills stayed home from work. Could not get out of bed until noon. Took 1g Tylenol did not help at 6am. Entire day chills fatigue 10-5-2021 10-6-2021: night sweats and day sweats but able to go to work and do daily activities  10-7-2021: 2am night sweat drenched
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Night sweats
Clinical narrative: 10/5/2021: chills, soreness injection site, headache, fatigue (12am) 6am: severe fatigue chills stayed home from work. Could not get out of bed until noon. Took 1g Tylenol did not help at 6am. Entire day chills fatigue 10-5-2021 10-6-2021: night sweats and day sweats but able to go to work and do daily activities  10-7-2021: 2am night sweat drenched
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Aptyalism, Dry mouth, Lip dry, Mastication disorder
Clinical narrative: Dry mouth.  Difficult to chew food.  Dry lips.  Loss of taste.  Low saliva.
Age: 56.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Awakened by onset of intense itching at 0300 both wrists and both flanks, rapid progression within 30 minutes (in spite of 50mg benadryl at 0315) to involve entire flexor surfaces of both arms with numerous and confluent urticarial wheals and redness, circumferential abdomen and lower trunk, behind and including both ears and lateral scalp, lateral thighs and posterior knees.  No oral swelling / mucosal involvement, no respiratory symptoms.  Itching subsided somewhat after 3 hours but wheals remained in above distribution with q 6 hour benadryl 50 mg + zyrtec 10 q 12 for 36 hours.  Began to fade somewhat at 24 hours, mostly resolved at 36 hours except on arms.  No prior similar reaction to anything prior in my life.  Discussed with PCP who prescribed steroid pack but as sx began to subside at 24hr did not take.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Rash
Clinical narrative: Broke out in a full body rash 5 days later. Itching most intense on palms of hands. Redness, burning, severe itching with little relief.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Ear discomfort, Ear pain, Hyperacusis, Tinnitus
Clinical narrative: anxiety; He feels ear pressure, pain; He feels ear pressure, pain and ear fullness/hurting his ears; ear fullness; sound sensitivity; ear ringing/tinnitus; hyperacusis; This is a spontaneous report from a contactable consumer (mother).   A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 17May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On unknown date in 2021, patient experienced ear ringing/tinnitus and hyperacusis. He got second dose on 17May2021. After this experience he got anxiety. He got sound sensitivity, sounds (whispering, footsteps to airplane), hurting his ears. He felt ear pressure, pain and ear fullness. It was reported that the patient visited ENT, neurologist and stated that no one can figure out how to cure it. He was basically isolated in a room. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Menstrual disorder
Clinical narrative: shortness of breath; Chest pain; I also haven't started my period and have been breaking out more than normal; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 10Aug2021 09:45 (at the age of 36-years-old) (Batch/Lot number and expiration date: was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On 14Aug2021 22:00 the patient experienced shortness of breath followed by chest pain 4 days after receiving the first dose. Patient also stated she haven't started her period and had been breaking out more than normal. The patient did not receive treatment for the events but visited emergency room for the same. Patient did not receive any other vaccines within 4 weeks and other medications within 2 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The patient underwent lab tests and procedures which included blood test: unspecified on an unspecified date in Aug2021, chest x-ray: unspecified on an unspecified date in Aug2021. The outcome of all the events was not recovered.   Follow-up activities closed: Batch/lot number not available for [Vaccine, BNT162B2]
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Movement disorder, Myalgia, Pyrexia
Clinical narrative: Fever to 101; Swollen nodes in armpit on the left side, tender and can barely move arm; Swollen nodes in armpit on the left side, tender and can barely move arm; Swollen nodes in armpit on the left side, tender and can barely move arm; myalgia; slept for 24 hrs; This is a spontaneous report from a contactable physician. A 61-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, Sulfa drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. On 12Aug2021 20:00 the patient experienced fever to 101, swollen nodes in armpit on the left side, tender and can barely move arm, swollen nodes in armpit on the left side, tender and can barely move arm, swollen nodes in armpit on the left side, tender and can barely move arm, myalgia, slept for 24 hrs. The outcome of the events was recovering. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on 12Aug2021, sars-cov-2 test: negative on 11Aug2021. Therapeutic measures were taken as a result of the events. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence, Tenderness
Clinical narrative: Fever to 101; Swollen nodes in armpit on the left side, tender and can barely move arm; Swollen nodes in armpit on the left side, tender and can barely move arm; Swollen nodes in armpit on the left side, tender and can barely move arm; myalgia; slept for 24 hrs; This is a spontaneous report from a contactable physician. A 61-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, Sulfa drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. On 12Aug2021 20:00 the patient experienced fever to 101, swollen nodes in armpit on the left side, tender and can barely move arm, swollen nodes in armpit on the left side, tender and can barely move arm, swollen nodes in armpit on the left side, tender and can barely move arm, myalgia, slept for 24 hrs. The outcome of the events was recovering. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on 12Aug2021, sars-cov-2 test: negative on 11Aug2021. Therapeutic measures were taken as a result of the events. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, SARS-CoV-2 test, Tinnitus
Clinical narrative: tinnitus ongoing since 2 dose Pfizer covid vaccine; Other vaccine same date vaccine date: 05Jan2021; Other vaccine same date vaccine date: 05Jan2021; This is a spontaneous report from a contactable other health care professional reported for herself (Nurse). A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 05Jan2021 (age at vaccination was 50 years) as dose number unknown, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 05Jan2021 (age at vaccination was 50 years) as dose number unknown, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination The patient's medical history included none. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 05Jan2021 the patient experienced tinnitus ongoing since 2 doses pfizer covid vaccine and other vaccine was given on same day in both arms, vaccine date: 05Jan2021. The patient underwent lab tests and procedures which included PCR/Nasal Swab which showed negative result on 16Aug2021. No treatment was received for the adverse events. The outcome of the event tinnitus was not resolved. The outcome of rest of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Headache, Pain
Clinical narrative: Coughing up blood; occasional headaches; achiness from work; This is a spontaneous report from a contactable consumer or other non hcp.   A 44-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 19Aug2021 as 1stdose, single for covid-19 immunisation (Age at vaccination was 44 years). The patient medical history and concomitant medications were not reported.  The patient experienced coughing up blood on an, occasional headaches, achiness from work on an unspecified date.  Therapeutic measures were taken as a result of occasional headaches. Patient confirms the that he is otherwise pretty healthy, does not even get the flu, and has no medical conditions aside from occasional headaches, for which he takes Excedrin. States he gets achiness from work, but not sure if he would be able to tell if that would be from the vaccine or not. He reports that he woke up at 4:30 AM, started coughing, looked at his hand, and saw blood. He felt like there was liquid in his lung, and when he coughed that out, it was blood. He thought he would do research to see if this is side effect, and states that he would rather reserve the ER for more serious things. Reports that he has never been to the hospital aside from for work. Thought it was more than a coincidence that he got this yesterday, and this happened today, again stating that he does not usually even get the flu. States that he will seek out an HCP, and maybe will get a lung x-ray. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: palpitations in her heart; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 46-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on an unknown date in Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. She received the first dose of the Pfizer-BioNTech COVID-19 Vaccine in Mar2021 and did not go for the second dose because after about 2 days she had palpitations in her heart. She had some cardiology work to check if everything was okay. She also asked her doctor for second dose and was advised to get the second dose. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not available and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: B-lymphocyte count, Immune system disorder
Clinical narrative: WBC's are also very low; she didn't get antibodies; States her immune system is so weak; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included sjogren's syndrome from an unknown date and unknown if ongoing , rheumatoid arthritis from an unknown date and unknown if ongoing States her rheumatoid syndrome is caused by that and she was diagnosed at age 27 years. Concomitant medication(s) included rituximab (RITUXAN) taken for rheumatoid arthritis from Oct2020 to an unspecified stop date. On an unspecified date the patient experienced WBCs are also very low, she didn't get antibodies and states her immune system is so weak on an unspecified date.The patient underwent lab tests and procedures which included: she has no B-cells, WBCs are also very low. She had antibody testing done 03JUN2021 for SARS-COV-2 Immuno essay, the results were neg. She had a 2nd antibody test (IGG) on 09Jun2021, and the test was also neg. States her sister has triple neg breast cancer and had no antibodies either following chemotherapy, not sure if she had the Pfizer Covid vaccine or Moderna. Caller is also waiting to find out her T-cell level. Caller states she just wanted to call and report that she got the Pfizer vaccine back in Apr2021 and was fine with no side effects, it was smooth with just a sore arm. State she got her last one 3 weeks later in May2021 and then started reading. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test negative, Anxiety, B-lymphocyte count, B-lymphocyte count decreased, Immunodeficiency
Clinical narrative: WBC's are also very low; she didn't get antibodies; States her immune system is so weak; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included sjogren's syndrome from an unknown date and unknown if ongoing , rheumatoid arthritis from an unknown date and unknown if ongoing States her rheumatoid syndrome is caused by that and she was diagnosed at age 27 years. Concomitant medication(s) included rituximab (RITUXAN) taken for rheumatoid arthritis from Oct2020 to an unspecified stop date. On an unspecified date the patient experienced WBCs are also very low, she didn't get antibodies and states her immune system is so weak on an unspecified date.The patient underwent lab tests and procedures which included: she has no B-cells, WBCs are also very low. She had antibody testing done 03JUN2021 for SARS-COV-2 Immuno essay, the results were neg. She had a 2nd antibody test (IGG) on 09Jun2021, and the test was also neg. States her sister has triple neg breast cancer and had no antibodies either following chemotherapy, not sure if she had the Pfizer Covid vaccine or Moderna. Caller is also waiting to find out her T-cell level. Caller states she just wanted to call and report that she got the Pfizer vaccine back in Apr2021 and was fine with no side effects, it was smooth with just a sore arm. State she got her last one 3 weeks later in May2021 and then started reading. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunosuppressant drug therapy, Infusion, Pain in extremity, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: WBC's are also very low; she didn't get antibodies; States her immune system is so weak; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included sjogren's syndrome from an unknown date and unknown if ongoing , rheumatoid arthritis from an unknown date and unknown if ongoing States her rheumatoid syndrome is caused by that and she was diagnosed at age 27 years. Concomitant medication(s) included rituximab (RITUXAN) taken for rheumatoid arthritis from Oct2020 to an unspecified stop date. On an unspecified date the patient experienced WBCs are also very low, she didn't get antibodies and states her immune system is so weak on an unspecified date.The patient underwent lab tests and procedures which included: she has no B-cells, WBCs are also very low. She had antibody testing done 03JUN2021 for SARS-COV-2 Immuno essay, the results were neg. She had a 2nd antibody test (IGG) on 09Jun2021, and the test was also neg. States her sister has triple neg breast cancer and had no antibodies either following chemotherapy, not sure if she had the Pfizer Covid vaccine or Moderna. Caller is also waiting to find out her T-cell level. Caller states she just wanted to call and report that she got the Pfizer vaccine back in Apr2021 and was fine with no side effects, it was smooth with just a sore arm. State she got her last one 3 weeks later in May2021 and then started reading. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: White blood cell count decreased
Clinical narrative: WBC's are also very low; she didn't get antibodies; States her immune system is so weak; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included sjogren's syndrome from an unknown date and unknown if ongoing , rheumatoid arthritis from an unknown date and unknown if ongoing States her rheumatoid syndrome is caused by that and she was diagnosed at age 27 years. Concomitant medication(s) included rituximab (RITUXAN) taken for rheumatoid arthritis from Oct2020 to an unspecified stop date. On an unspecified date the patient experienced WBCs are also very low, she didn't get antibodies and states her immune system is so weak on an unspecified date.The patient underwent lab tests and procedures which included: she has no B-cells, WBCs are also very low. She had antibody testing done 03JUN2021 for SARS-COV-2 Immuno essay, the results were neg. She had a 2nd antibody test (IGG) on 09Jun2021, and the test was also neg. States her sister has triple neg breast cancer and had no antibodies either following chemotherapy, not sure if she had the Pfizer Covid vaccine or Moderna. Caller is also waiting to find out her T-cell level. Caller states she just wanted to call and report that she got the Pfizer vaccine back in Apr2021 and was fine with no side effects, it was smooth with just a sore arm. State she got her last one 3 weeks later in May2021 and then started reading. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain in extremity
Clinical narrative: severe muscular body aches all over her body especially her legs and back; severe muscular body aches all over her body especially her legs and back; severe muscular body aches all over her body especially her legs and back; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on Jun2021 as DOSE 2, SINGLE (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the second dose of the Pfizer COVID-19 vaccine some time in June, exact date unknown. Since June, patient has severe muscular body aches all over her body, especially in her legs and back. Reporter reported that there has been an increase in intensity since July. Patient stands up most of the day to work. The outcome of the events was not resolved.   No further details were provided or obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: Chills; Feeling unwell; Fatigue; Headache; Fast heartbeat; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Aug2021 09:15 (at the age of 74-years-old) as dose 2, single for covid-19 immunization at pharmacy or drug Store. The patient medical history included atrial fibrillation (Other medical history: Afib). Concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in right arm on 29Jul2021 04:45 PM (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. The patient does not have any allergies. No other vaccine was received within four weeks. Other medications were received in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 19Aug2021 07:45 PM the patient experienced chills, feeling unwell, fatique, tiredness, headache, fast heartbeat, arm pain. The patient underwent lab tests and procedures which included fast heartbeat (heart rate): fast on 19Aug2021. No treatment was received for adverse event. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: Chills; Feeling unwell; Fatigue; Headache; Fast heartbeat; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Aug2021 09:15 (at the age of 74-years-old) as dose 2, single for covid-19 immunization at pharmacy or drug Store. The patient medical history included atrial fibrillation (Other medical history: Afib). Concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in right arm on 29Jul2021 04:45 PM (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. The patient does not have any allergies. No other vaccine was received within four weeks. Other medications were received in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 19Aug2021 07:45 PM the patient experienced chills, feeling unwell, fatique, tiredness, headache, fast heartbeat, arm pain. The patient underwent lab tests and procedures which included fast heartbeat (heart rate): fast on 19Aug2021. No treatment was received for adverse event. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: Fevery 100.5, headache, body aches, congestion, fatigue; Fevery 100.5, headache, body aches, congestion, fatigue; Fevery 100.5, headache, body aches, congestion, fatigue; Fevery 100.5, headache, body aches, congestion, fatigue; Fevery 100.5, headache, body aches, congestion, fatigue; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in Arm Left, on 20Aug2021 18:30 (at the age of 14-year-old), as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not have any known allergies. The patient did not receive any other vaccine in four weeks and any other medications in two weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in Left arm on 03Aug2021 04:30 PM (at the age of 14 years old) for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 21Aug2021 at 23:00, the patient experienced Fevery 100.5, headache, body aches, congestion, fatigue. The patient did not receive any treatment for the events. Outcome of the events was recovering.  Follow attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vein disorder
Clinical narrative: Vein that goes up in his neck has a little knot in it; Vein is really puffed up and have that knot in it where he got the shot; This is a spontaneous report from a contactable consumer (patient) reported for a male patient. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number, Expiration date were not provided), via an unspecified route of administration on 18Aug2021 (at the age of 52-years) as dose 1, Single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was reported that fiance got the shot and now he had the vein that goes up in his neck had a little knot in it and the thing was the vein was really puffed up and had that knot in it where he got the shot, well same side he got the shot on. Reporter queried for concerning the side effects from the shot, does patient need to get to the hospital. Reporter stated that drug was Pfizer, the two shot the Pfizer, the two shot for the COVID. Reporter confirmed that patient received the first one, he had not received the second one. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. 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: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, Aug 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Patient is calling regarding the Pfizer COVID-19 vaccine. Reportedly, she got the COVID-19 vaccine last Friday. On Aug 19, 2021, patient experienced right leg pain. Since yesterday, she has been having right leg pain. She questioned if she was supposed to go to the hospital. The outcome of the events: not recovered. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. Follow-up (Oct 1, 2021): 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 completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Photophobia, Throat tightness
Clinical narrative: very sensitive to outdoor light; really tight throat that is a little hard to breathe; really tight throat that is a little hard to breathe; super anxious; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 12Aug2021 12:00 at the age of 29-years-old as DOSE 1, SINGLE for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination.The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination.The patient medical history was not reported.The patient's concomitant medications were not reported.On 12Aug2021 14:00 the patient experienced very sensitive to outdoor light, really tight throat that is a little hard to breathe, super anxious. The patient was not received any treatment .The outcome of event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Body pain; Was feeling exhausted; I felt really back like I had the flu or something; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 64-year-old male patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 (afternoon) (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 64-year-old) for covid-19 immunisation. It was reported that no additional vaccines administered on same date of the Pfizer suspect. Medical history included COVID-19 (was not hospitalized when he had Covid 9 months ago), Neck was injured (states his neck was injured in 2009), Major sleep problems and Drowsy. There were no concomitant medications (no other products). The patient did not have any family medical history relevant to events. The patient stated his neck was injured in 2009, that was the reason for major sleep problems. When the patient was sitting up watching tv he can be drowsy, and as soon as the caller lays down the drowsiness goes away because the weight was off the vertebrae in the lower part of the neck. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have any event prior vaccinations. The patient experienced body pain, was feeling exhausted and he felt really back like he had the flu or something on 09Apr2021. The patient stated that the reason for body pain and was feeling exhausted after receiving the first dose Pfizer Covid 19 Vaccine probably happened because the caller had Covid 9 months ago, but got over Covid in 6 weeks. The caller was not hospitalized when he had Covid 9 months ago. It was reported that patient was given medicine to fight the Covid prior to receiving either dose of the Pfizer Covid 19 Vaccine. The patient does not have his vaccination card. The patient stated the nurse at the doctor's office gave the first dose Pfizer Covid Vaccine and the patient had to sit in the lobby for 1 hour before he left the office. It was reported that no emergency room and physician office visit required for this events. No any relevant tests done. The patient want to know need to receive third dose Pfizer Covid Vaccine, will be totally immun-ized and asking if this was true. The patient received second dose of bnt162b2 on 01Jul2021 for covid-19 immunisation. The outcome of events reported as recovered on 10Apr2021.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Dizziness, Palpitations
Clinical narrative: light headed; heart palpitations; chest pains; heart still feels slight tightness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number and expiry date: unknown) (age at the time of vaccination was 60 years old and patient was non-pregnant at the time of vaccination) via an unspecified route of administration, administered in arm left on 18Aug2021 17:15 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included high blood pressure, high cholesterol, mild valve regurgitation and arthritis and known allergies to Penicillin, Sulfas and Pistachio nuts. Concomitant medications included/list of any other medications the patient received within 2 weeks of vaccination Lisinopril, Metoprolol, Rosuvastatin and Celebres. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Aug2021 17:15, the patient became lightheaded within two or three minutes, but that subsided quickly. After thirty minutes later, the patient started having palpitations and chest pains that lasted the rest of that night and most of the next day. The patient felt still feels slight tight. The patient did not receive any treatment for the events. The outcome of the events light headed was recovered/resolved in 2021 and unknown for other events.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up. Follow-up attempts are completed. No further information was expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: headache; This is a spontaneous report from a contactable consumer or other non healthcare professional.This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's father) reported for a 18-year-old female patient (reporter's daughter) that: A 18 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation..The patient medical history and concomitant medications were not reported. The patient experienced headache on 17Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test:with unknown results.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk, Rash
Clinical narrative: 24hrs after shot, my breasfed 1month old baby developed a rash on face and chest.; 24hrs after shot, my breasfed 1month old baby developed a rash on face and chest.; This is a spontaneous report from a contactable consumer (mother). This is second of 2 reports. This 38-year-old non-pregnant female mother reported for her child. An infant of 01-month-old patient unspecified gender received was exposed to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3183), via an unspecified route of administration at left arm, on 21Aug2021 at 14:15 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 22Aug2021 at 14:15, the patient experienced 24hrs after shot, my breastfed 1month old baby developed a rash on face and chest. Mother was 14wks pregnant when she tested positive for Covid she was sick for approx. 5-6 weeks but never like this. No treatment was received. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101090194 Maternal case
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Severe back, knee and hip pain; Severe back, knee and hip pain; Severe back, knee and hip pain; Muscle stiffness; Slowed mobility; This is a spontaneous report from a contactable pharmacist (patient). A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 07Aug2021 (at the age of 37-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Facility type vaccine was Pharmacy or Drug Store. The patient medical history was not reported. No other vaccine in four weeks. There were no concomitant medications. No covid prior vaccination and covid was not tested post vaccination. The patient experienced severe back, knee and hip pain, muscle stiffness, slowed mobility on 14Aug2021. AE resulted in none of the above (unspecified details). No treatment was received for the events. Clinical outcome of events was not recovered.  Information about lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever; Sore throat; This is a spontaneous report from a contactable consumer (patient).   A 12-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number/Expiry date: Not reported) via an unspecified route of administration, administered in right arm on 21Aug2021 at 15:45 (age at vaccination was 12-years) as dose 1, single for COVID-19 immunisation. Patient medical history included seasonal asthma from an unknown date and unknown if ongoing. Concomitant medication was not reported. On 21Aug2021 at 03:15, the patient experienced fever and sore throat. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 post vaccination. The patient underwent lab tests included body temperature: fever 2 days later on 21Aug2021. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow-up.