chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Occipital neuralgia, Pain assessment, Pain in jaw, Toothache
Clinical narrative: occipital neuralgia; Horrible head pain right side from base of scull to forehead and jaws and teeth and eye and ear; Horrible head pain right side from base of scull to forehead and jaws and teeth and eye and ear; Horrible head pain right side from base of scull to forehead and jaws; Horrible head pain right side from base of scull to forehead and jaws and teeth; Horrible head pain right side from base of scull to forehead and jaws and teeth and eye; Pain radiates down neck and trapezoid on right.; Pain radiates down neck and trapezoid on right.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7534) via an unspecified route of administration in left arm on an unspecified date in Mar2021 as single dose for COVID-19 immunization. Medical history of the patient included diabetes, pulmonary embolisms from trauma, kidney stones. Concomitant (other) medications in two weeks included metformin and glipizide taken for Diabetes and warfarin sodium [COUMADIN] taken for an unspecified indication. Patient did not receive any other vaccine in four weeks of COVID vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has allergy to mushrooms, iodine dye, aloe. On an unspecified date in Mar2021, patient experienced horrible head pain right side from base of skull to forehead and jaws and teeth and eye and ear, originally called occipital neuralgia. Pain was still there after 5 months. 10 on scale of 1 to 10. Pain radiates down neck and trapezoid on right. Patient never had headaches before this shot. Patient was taking oxycodone and gabapenten and Memantine. Adverse event resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Reporter assessed events as serious causing Disability or permanent damage. Corrective treatment included Pain meds, acupuncture and cupping, TENS. Outcome of the events were not recovered.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives in right hand, shoulder, and face; This is a spontaneous report from a non contactable consumer (patient).  A 51-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Aug2021 (Batch/Lot Number: Fa7484) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, triamterene (DIU) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient experienced hives in right hand, shoulder and face on 04Aug2021; event was considered as non serious (no hospitalization required). Therapeutic measures were taken as a result of the event and included administration of daily Benadryl. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered    No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chills, Dizziness, Hypertension, Pain
Clinical narrative: by Sun. 31Jul, I checked myself into a hospital and my blood pressure was 207/94. I was given medication for BP, but it is still very erratic.; Suddenly on 25Jul I began vomiting which lasted into that night; For the next 5 days I remained very dizzy; The day after that shot I had fever, chills and soreness.; The day after that shot I had fever, chills and soreness.; The day after that shot I had fever, chills and soreness.; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports with events experienced under the second dose. A 73-year-old female patient not pregnant received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Feb2021 14:15 (Lot Number: EL9267) as single dose (at age of 73-year-old) for covid-19 immunisation. Medical history included allergies to sulfa and penicillin, sjogren's syndrome, hypo thyroid. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID). The patient previously took first dose of bnt162b2 (BNT162B2) for covid-19 immunisation on 21Jan2021 03:15 PM in Left arm, lot number: EL9263 (at age of 73-year-old) and experienced pain in extremity (first vaccine shot 21Jan2021, her arm was very sore for 3 days), she previously received amoxicillin, clavulanic acid (AUGMENTIN) and experienced drug hypersensitivity. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient stated that her blood pressure had been 110/70 her whole life. Her first vaccine shot was on 21Jan2021, her arm was very sore for 3 days. Patient had her second shot on 18Feb2021. The day after that shot (19Feb2021) she had fever, chills and soreness. Suddenly on 25Jul2021 at 09:30 she began vomiting which lasted into that night. For the next 5 days she remained very dizzy, on 31Jul2021 patient checked herself into a hospital and her blood pressure was 207/94, she was given medication for blood pressure (BP), but it was still very erratic. The patient was hospitalized for blood pressure was 207/94, vomiting and dizziness for 2 days. Events blood pressure was 207/94, vomiting and dizziness resulted in Emergency room/ department or urgent care, hospitalization and they were treated with blood pressure and anti vomiting medications. Since the vaccination, the patient has been tested for COVID-19, on 31Jul2021 with Nasal Swab and result was negative. Patient had not recovered from blood pressure was 207/94 and dizziness, she recovered on unknown date from Vomiting, while outcome of the other mentioned events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101025465 same patient/reporter, different vaccine dose/AE
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: by Sun. 31Jul, I checked myself into a hospital and my blood pressure was 207/94. I was given medication for BP, but it is still very erratic.; Suddenly on 25Jul I began vomiting which lasted into that night; For the next 5 days I remained very dizzy; The day after that shot I had fever, chills and soreness.; The day after that shot I had fever, chills and soreness.; The day after that shot I had fever, chills and soreness.; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports with events experienced under the second dose. A 73-year-old female patient not pregnant received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Feb2021 14:15 (Lot Number: EL9267) as single dose (at age of 73-year-old) for covid-19 immunisation. Medical history included allergies to sulfa and penicillin, sjogren's syndrome, hypo thyroid. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID). The patient previously took first dose of bnt162b2 (BNT162B2) for covid-19 immunisation on 21Jan2021 03:15 PM in Left arm, lot number: EL9263 (at age of 73-year-old) and experienced pain in extremity (first vaccine shot 21Jan2021, her arm was very sore for 3 days), she previously received amoxicillin, clavulanic acid (AUGMENTIN) and experienced drug hypersensitivity. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient stated that her blood pressure had been 110/70 her whole life. Her first vaccine shot was on 21Jan2021, her arm was very sore for 3 days. Patient had her second shot on 18Feb2021. The day after that shot (19Feb2021) she had fever, chills and soreness. Suddenly on 25Jul2021 at 09:30 she began vomiting which lasted into that night. For the next 5 days she remained very dizzy, on 31Jul2021 patient checked herself into a hospital and her blood pressure was 207/94, she was given medication for blood pressure (BP), but it was still very erratic. The patient was hospitalized for blood pressure was 207/94, vomiting and dizziness for 2 days. Events blood pressure was 207/94, vomiting and dizziness resulted in Emergency room/ department or urgent care, hospitalization and they were treated with blood pressure and anti vomiting medications. Since the vaccination, the patient has been tested for COVID-19, on 31Jul2021 with Nasal Swab and result was negative. Patient had not recovered from blood pressure was 207/94 and dizziness, she recovered on unknown date from Vomiting, while outcome of the other mentioned events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101025465 same patient/reporter, different vaccine dose/AE
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anion gap, Blood chloride, Blood potassium, COVID-19, Carbon dioxide
Clinical narrative: This is a spontaneous report from a contactable physician. A 66-year-old female patient received the second dose of BNT162B2 at 66-year-old, via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) at single dose, and the first dose via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER8730; Expiration Date: 30Jul2021) at single dose for COVID-19 immunisation. Medical history included congestive heart failure, chronic obstructive pulmonary disease (COPD), diabetes, high blood pressure, and chronic kidney disease. Concomitant medications included furosemide, BREO ELLIPTA, carvedilol, insulin, losartan, and metformin. The patient had BNT162B2 and was tested positive COVID on 17Jul2021. Reporter assumed that it was delta variant, but did not know for sure. They did not know for sure, so they were sequencing DNA sample. After COVID, patient was put on dexamethasone treatment. It was 6 mg for 10 days. Patient also had not a BMP but a CMP a week before. So, low potassium, high chloride, low carbon dioxide, and a mildly elevated anion gap, the number was 12, anion gap was 12. Outcome of the events was unknown. Based on the information currently available, The casual association between the reported event Covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable physician. A 66-year-old female patient received the second dose of BNT162B2 at 66-year-old, via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) at single dose, and the first dose via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER8730; Expiration Date: 30Jul2021) at single dose for COVID-19 immunisation. Medical history included congestive heart failure, chronic obstructive pulmonary disease (COPD), diabetes, high blood pressure, and chronic kidney disease. Concomitant medications included furosemide, BREO ELLIPTA, carvedilol, insulin, losartan, and metformin. The patient had BNT162B2 and was tested positive COVID on 17Jul2021. Reporter assumed that it was delta variant, but did not know for sure. They did not know for sure, so they were sequencing DNA sample. After COVID, patient was put on dexamethasone treatment. It was 6 mg for 10 days. Patient also had not a BMP but a CMP a week before. So, low potassium, high chloride, low carbon dioxide, and a mildly elevated anion gap, the number was 12, anion gap was 12. Outcome of the events was unknown. Based on the information currently available, The casual association between the reported event Covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Experienced extreme bad headache; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA 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. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that someone in the building got the Pfizer coviid-19 vaccine and experienced extreme bad headache. She used that excuse from doctor to not get the second dose. I know so many people dying after received the Pfizer. The woman in her building who had the first dose awful headaches and could not move from the bed and she did not do the second dose. It was stated they gave her a strong dose of antihistamine before the vaccine. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: He got a got blood clot; This is a spontaneous report from a contactable lawyer. This lawyer (patient's wife) reported for a male patient (reporter's husband) of an unspecified age received BNT162B2 (PFIZ-ER COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history, concomitant medications and past drug therapy were not reported. The reporter husband had Pfizer vaccine and he got a blood clot. The outcome of the event was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 after having both Pfizer vaccinations. His symptoms included fever, cough, runny nose, sinus pressure and headache; tested positive for Covid-19 after having both Pfizer vaccinations. His symptoms included fever, cough, runny nose, sinus pressure and headache; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbers and expiration dates were not provided), via an unspecified route of administration on an unspecified date at dose 1, single and 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 tested positive for COVID-19 on 27Jul2021 (also reported as 27Jul2020) after having both doses of Pfizer vaccine. His symptoms included fever, cough, runny nose, sinus pressure and headache. He is currently recovering at home. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Urticaria
Clinical narrative: Hives; pain; allergy; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 40-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 15:00 (Batch/Lot Number: EWO180) as dose 2, single for covid-19 immunisation at the age of 40-year-old. Medical history included ongoing type 2 diabetes mellitus. Concomitant medications included dapagliflozin propanediol monohydrate (FARXIGA); metformin; lisinopril; vitamin D. No other vaccine received in four weeks. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 15:00 (Batch/Lot Number: EWO179) as dose 1, single for covid-19 immunisation at the age of 40-year-old. The patient experienced hives, pain, allergy on 10Jun2021 20:00 (also reported as 20Jun2021). Therapeutic measures were taken as a result of hives, pain, allergy. The events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization. The outcome of events was not recovered. Clinical course was reported as: the patient experienced severe hives all over the body. Started on 20Jun2021 and the patient was taken to Emergency Room on 10Jul2021 with unbearable pain and hives spreading from head to toe. Initially the patient realized this might be an allergy, but the hives did not subside for more than 4 weeks. Per consultation from allergist the patient took Benadryl and then Allegra, however the hives continues to trouble him and he was in lot of pain. At ER ROOM, the patient was given Decadron and Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough infection, positive for COVID 19; breakthrough infection, positive for COVID 19; This is a spontaneous report from a contactable nurse communicated through a Pfizer Sales Representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced breakthrough infection, positive for COVID 19 on an unspecified date. Outcome of the events was unknown.   Information on batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Drug ineffective and COVID-19 cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid pneumonia; Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable physician and a contactable consumer (company representative). An 83-years-old male 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 unknown date in January 2021 as DOSE 1, SINGLE; and dose 2 via an unspecified route of administration on an unknown date in January 2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history included prostate cancer (currently undergoing radiation for prostate cancer. It was not sure if the patient was undergoing radiation therapy at time of vaccine). The patient's concomitant medications were not reported. The patient had both Pfizer vaccines in January2021. On an unknown date, the patient was tested positive for covid. On an unknown date, the patient progressed to Covid pneumonia. The patient was hospitalized for covid pneumonia (covid-19 pneumonia) from 08Aug2021 over the weekend. Events took place after use of product. The patient on an unknown date underwent Covid test which was positive. The patient was treated with Z PACK and steroid and put in isolation. The outcome of tested positive for Covid and Covid pneumonia was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported lack of efficacy  events  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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Respiratory symptom, SARS-CoV-2 test
Clinical narrative: symptomatic w upper respiratory symptoms; break through COVID diagnosis per urgent care/positive COVID test; break through COVID diagnosis per urgent care/positive COVID test; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Feb2021 as Dose number unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Jul2021, patient experienced break through COVID diagnosis per urgent care/positive covid test, symptomatic w upper respiratory symptoms on an unspecified date. Reported that event took place after use of product. Patient did not wish to be contacted for follow-up. The patient underwent lab tests and procedures which included COVID test: positive on 31Jul2021. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Asthma, Diarrhoea, Dizziness
Clinical narrative: Rash on leg and left hand, top of hands/Rash; itching on top of the left hand started today; weakness; Diarrhea; feeling tired; Light-headed; Stomach pain; felt sick to stomach; felt sick; body aching; his arm is sore/soreness in arm; Says his asthma acted up; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution of injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 07Aug2021 (at the age of 19-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing narrowing of the main vein in his heart, instead it was going straight. They were going to do open heart surgery, but it fixed itself, hypersensitivity from an unknown date and unknown if ongoing he has allergies. The patient's concomitant medications were not reported. On Aug2021, the patient experienced, nausea and says his asthma acted up. On 08Aug2021, the patient experienced his arm is sore/soreness in arm, diarrhoea, feeling tired, light-headed, stomach pain, felt sick to stomach; felt sick, body aching. On 09Aug2021, the patient experienced weakness. On 10Aug2021, the patient experienced top of hands/rash, itching on top of the left hand started today a rash on leg and left hand, top of hands/rash. Reporter reports her son received the first dose of the Pfizer Covid 19 vaccine on 07Aug2021 and 24 hours later he began to experience side effects of soreness in the arm, diarrhea, and rash, feeling tired and lightheaded, stomach pain, and now today he began to have a rash on the leg and left hand. He has ADHD, has asthma and a heart condition. Had called to verify that these are side effect. Reporter clarifies patient had ADHD, asthma, and heart condition at birth before administration of product. Later provides patient was born with a heart condition, with narrowing of the main vein in his heart, instead it was going straight. They were going to do open heart surgery, but it fixed itself. Therapeutic measures were taken as a result of, itching on top of the left hand started today (pruritus), says his asthma acted up (asthma). The outcome of the event arm was sore/soreness in arm, weakness, diarrhoea, feeling tired, felt sick to stomach; felt sick, body aching, says his asthma acted up was unknown and the remaining all events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Nausea, Pain, Pain in extremity
Clinical narrative: Rash on leg and left hand, top of hands/Rash; itching on top of the left hand started today; weakness; Diarrhea; feeling tired; Light-headed; Stomach pain; felt sick to stomach; felt sick; body aching; his arm is sore/soreness in arm; Says his asthma acted up; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution of injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 07Aug2021 (at the age of 19-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing narrowing of the main vein in his heart, instead it was going straight. They were going to do open heart surgery, but it fixed itself, hypersensitivity from an unknown date and unknown if ongoing he has allergies. The patient's concomitant medications were not reported. On Aug2021, the patient experienced, nausea and says his asthma acted up. On 08Aug2021, the patient experienced his arm is sore/soreness in arm, diarrhoea, feeling tired, light-headed, stomach pain, felt sick to stomach; felt sick, body aching. On 09Aug2021, the patient experienced weakness. On 10Aug2021, the patient experienced top of hands/rash, itching on top of the left hand started today a rash on leg and left hand, top of hands/rash. Reporter reports her son received the first dose of the Pfizer Covid 19 vaccine on 07Aug2021 and 24 hours later he began to experience side effects of soreness in the arm, diarrhea, and rash, feeling tired and lightheaded, stomach pain, and now today he began to have a rash on the leg and left hand. He has ADHD, has asthma and a heart condition. Had called to verify that these are side effect. Reporter clarifies patient had ADHD, asthma, and heart condition at birth before administration of product. Later provides patient was born with a heart condition, with narrowing of the main vein in his heart, instead it was going straight. They were going to do open heart surgery, but it fixed itself. Therapeutic measures were taken as a result of, itching on top of the left hand started today (pruritus), says his asthma acted up (asthma). The outcome of the event arm was sore/soreness in arm, weakness, diarrhoea, feeling tired, felt sick to stomach; felt sick, body aching, says his asthma acted up was unknown and the remaining all events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on leg and left hand, top of hands/Rash; itching on top of the left hand started today; weakness; Diarrhea; feeling tired; Light-headed; Stomach pain; felt sick to stomach; felt sick; body aching; his arm is sore/soreness in arm; Says his asthma acted up; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution of injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 07Aug2021 (at the age of 19-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing narrowing of the main vein in his heart, instead it was going straight. They were going to do open heart surgery, but it fixed itself, hypersensitivity from an unknown date and unknown if ongoing he has allergies. The patient's concomitant medications were not reported. On Aug2021, the patient experienced, nausea and says his asthma acted up. On 08Aug2021, the patient experienced his arm is sore/soreness in arm, diarrhoea, feeling tired, light-headed, stomach pain, felt sick to stomach; felt sick, body aching. On 09Aug2021, the patient experienced weakness. On 10Aug2021, the patient experienced top of hands/rash, itching on top of the left hand started today a rash on leg and left hand, top of hands/rash. Reporter reports her son received the first dose of the Pfizer Covid 19 vaccine on 07Aug2021 and 24 hours later he began to experience side effects of soreness in the arm, diarrhea, and rash, feeling tired and lightheaded, stomach pain, and now today he began to have a rash on the leg and left hand. He has ADHD, has asthma and a heart condition. Had called to verify that these are side effect. Reporter clarifies patient had ADHD, asthma, and heart condition at birth before administration of product. Later provides patient was born with a heart condition, with narrowing of the main vein in his heart, instead it was going straight. They were going to do open heart surgery, but it fixed itself. Therapeutic measures were taken as a result of, itching on top of the left hand started today (pruritus), says his asthma acted up (asthma). The outcome of the event arm was sore/soreness in arm, weakness, diarrhoea, feeling tired, felt sick to stomach; felt sick, body aching, says his asthma acted up was unknown and the remaining all events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, SARS-CoV-2 test, Thrombosis
Clinical narrative: when she got her second dose on that Friday, within 2 hours, she was back to heavy bleeding.; In the last 48 hours, she started passing blood clots again; This is a spontaneous report from a contactable consumer (patient).     A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EW0186) via an unspecified route of administration in right arm on 06Aug2021 (at 48 years)as single dose for covid-19 immunisation.  Medical history included Covid 19 virus from Oct2020 and did have a change to her menstrual cycles after having the Covid 19 virus. She would have a period then she would skip a period, she has had 3 vaginal births (her children are 27, 21, and 13 years old). She doesn't have a history of bleeding disorders; she had big blood clots after her daughters were born especially the last one 13 years ago. Concomitant medication included cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported.On 10Jul2021 (at the age of 48 years) patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EW0181) in right arm for covid-19 immunisation and 9 days later she was passing large golf ball sized clots, experienced abnormal vaginal bleeding that got heavier and heavier, HCPs think maybe the type of vaccine (mRNA) led her to possibly have early diagnosis of uterine cancer, she lost so much blood had to have transfusion, she had her period a week previously so knew it wasn't time for one( It was heavy for the first 7 days, wouldn't stop, then got heavier), thickened endometrium, complex hyperplasia, was frustrated, had hemoglobin at 8/ 5.Patient got a Rubella shot when she was 18 years old (30 years ago, as reported) and she got encephalitis after the Rubella vaccine. She had severe headaches for 3 weeks. The doctor thought it was related to the Rubella vaccine.On 06Aug2021, she got her second Covid 19 vaccine and in the night (within 2 hours) she was back to heavy bleeding, she started bleeding heavily even though she took medroxyprogesterone 10 mg. She's still bleeding now after the second Covid 19 vaccine. The caller thought her bleeding was related to the Covid 19 vaccine but her doctor thinks she's crazy. In the last 48 hours (Aug2021), she started passing blood clots again. Medroxyprogesterone wasn't stopping it this time .The outcome of bleeding was not recovered; outcome of blood clots was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101023313 Same patient/Vaccine, different event, different vaccine dose
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: developed widespread bloodclots; This is a spontaneous report from a contactable consumer for female patient (mother).  A female patient of an unspecified age received bnt162b2 (COVID-19 vaccine), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose bnt162b2 for covid-19 immunisation on Feb2021.  The patient developed widespread bloodclots on 2021 with fatal outcome.  The patient died on 2021.  It was not reported if an autopsy was performed. The clinical course was reported as follows: patient received the COVID-19 vaccine and developed widespread blood clots. Her first dose was in February, her second dose in March and 13 days later she was gone.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Developed widespread bloodclots
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Infection, SARS-CoV-2 test
Clinical narrative: Positive for COVID 19; Positive for COVID 19; Breakthrough infection; This is a spontaneous report from a contactable other healthcare professional via sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on an unspecified date, at dose number unknown,  single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced breakthrough infection and positive for COVID 19 on an unspecified date after vaccination. The patient underwent lab tests and procedures which included covid-19 test on an unspecified date which showed positive result. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported Covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received their first doses of the Pfizer covid 19 vaccines on 29JUN2021. His parents were diagnosed with COVID 19 after wards.; received their first doses of the Pfizer covid 19 vaccines on 29JUN2021. His parents were diagnosed with COVID 19 after wards.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional for a female patient (reporter's mother) and report 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 Expiry date: Unknown), via an unspecified route of administration on 29Jun2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Jun2021, the patient received their first doses of the Pfizer COVID-19 vaccines. On an unknown date in 2021, his parents were diagnosed with COVID 19 after wards. The patient underwent lab tests and procedures which included sars-cov-2 test was diagnosed with covid-19 on 2021 diagnosed with COVID 19. The outcome of the event covid-19 was recovered on an unknown date in 2021, the other event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Infection, SARS-CoV-2 test
Clinical narrative: Positive for COVID 19; Positive for COVID 19; Breakthrough infection; This is a spontaneous report from a contactable other hcp received via a sales representative. A male patient of an unspecified age received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had breakthrough infection and found positive for COVID-19 on an unspecified date. It was reported that event took place after the use of product.  The patient underwent lab tests and procedures which included, on an unspecified date, SARS-COV-2 test: positive.  The outcome of the events was unknown.  The lot number was not provided and will be requested during follow up.
Sex: F
Vaccine: PNC13
Symptoms: Autoimmune disorder
Clinical narrative: Indicates autoimmune disease; This is a spontaneous report based on information received by Pfizer from Merck  service centre [01983572]. A contactable female consumer (patient) reported a female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced indicates autoimmune disease on an unspecified date. The consumer inquiring if the vaccine is a live vaccine as she reported it has just been " discovered" she has an autoimmune disease (unspecified). "it is not epstein-barr, but something is decreased which indicates autoimmune disease". The customer reported she received the Prevnar 13 vaccine a year ago (unspecified date) and after the vaccine, her symptoms started. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have COVID after receiving the Pfizer vaccines in Dec and Jan; I have COVID after receiving the Pfizer vaccines in Dec and Jan; This is a spontaneous report from a contactable consume (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date in Dec2020 as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After received the Pfizer vaccines in Dec2020 and Jan2021, patient had COVID on an unknown date in 2021. Patient was concerned that it might happen given the information from (Withheld) and had earlier looked for trials to participate in on waning immunity. It was not my intention to substitute that by traveling to (Withheld) to pick up my granddaughter, however. Patient support WHO position on holding off on booster shots until there was greater vaccination world-wide. If there was any way patient can volunteer to better understand this, patient was willing. The patient underwent lab tests and procedures which included COVID test: had COVID on an unspecified date in 2021. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated
Clinical narrative: Indicates autoimmune disease; Symptoms have become worse; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first and second dose of bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Apr2021 (Lot number was not reported), dose 2 via an unspecified route of administration in Apr2021 (Lot number was not reported), both as single doses for covid-19 immunisation. Medical history included autoimmune disorder. Concomitant medications were not reported. Patient previously received pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) on unknown date in 2020 for immunisation and experienced autoimmune disorder (her symptoms started, unspecified). It was reported that patient called with a question about PNEUMOVAX 23 (customer has not received the PNEUMOVAX 23 vaccine at this time but is scheduled to get the vaccine later the day of the report). Patient inquiring if the vaccine is a live vaccine as she reported it has just been "discovered" she has an autoimmune disease (unspecified). "It is not Epstein-Barr, but something is decreased which indicates autoimmune disease". The patient reports she received the PREVNAR 13 vaccine a year before the time of the report (unspecified date in 2020) and after the vaccine, her symptoms started. The patient then stated she received the Pfizer COVID-19 shots in Apr2021 and "in the last few months" her symptoms have become worse (onset date 2021). The customer just wants to know if the PNEUMOVAX 23 vaccine is a live vaccine". No additional information provided. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chills, Dizziness, Headache, Pyrexia
Clinical narrative: fainting after first vaccine; Headache, after first vaccine; Fever, after first vaccine; Chills, after first vaccine; Dizziness; Loss of smell after first vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Aug2021 (at unknown age) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Agent states the Caller took her first dose of the Pfizer vaccine on 04Aug2021. Agent states the Caller reports having a headache, fever, chills, dizziness and fainting, and loss of smell, all on Aug2021. Caller confirms she is calling about the Pfizer COVID vaccine. Caller states she was calling her doctor, because she still had some dizziness and a loss of smell, and all of her other symptoms went away. Caller states she was trying, to make an appointment with her doctor, and they told her to call Pfizer. So she is not really sure what to do. The outcome of the events dizziness and a loss of smell was not recovered, for other events was recovered in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainting after first vaccine; Headache, after first vaccine; Fever, after first vaccine; Chills, after first vaccine; Dizziness; Loss of smell after first vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Aug2021 (at unknown age) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Agent states the Caller took her first dose of the Pfizer vaccine on 04Aug2021. Agent states the Caller reports having a headache, fever, chills, dizziness and fainting, and loss of smell, all on Aug2021. Caller confirms she is calling about the Pfizer COVID vaccine. Caller states she was calling her doctor, because she still had some dizziness and a loss of smell, and all of her other symptoms went away. Caller states she was trying, to make an appointment with her doctor, and they told her to call Pfizer. So she is not really sure what to do. The outcome of the events dizziness and a loss of smell was not recovered, for other events was recovered in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: arm that I got the shot in is reddened and swollen and there is pain; arm that I got the shot in is reddened and swollen and there is pain; tiny little red spots; tiny little bit of aching; a little itchy all over too; arm was really sore and hurting and I noticed it had turned red; my arm is very uncomfortable; This is a spontaneous report from a contactable nurse (patient).  A 58-Year-Old female patient received second dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Aug2021 single dose in left arm for COVID-19 immunisation. Lot number was FA7484. Medical history and concomitant medications were unknown. On 14Jul2021, the patient received first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation and she experienced sore in arm (lot number FA6780). On unknown date, the patient received a flu shot for immunization (inflamed, painful). The patient experienced arm that got the shot in was reddened and swollen and there was pain, tiny little red spots; tiny little bit of aching, a little itchy all over too, arm was really sore and hurting and it had turned red, arm was very uncomfortable. Little spots treated with antibiotics cream; the patient also received Benadryl and a Claritin, Ibuprofen 200 milligram. The outcome of the events was unknown.