chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Adverse event, Dizziness, Eye movement disorder, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Blacked out; saw "stars" before it went black; Ears were ringing; Very light headed; soreness in her leg; patient received meningococcal group b rlp2086 in the leg; This is a spontaneous report from a contactable consumer (patient's parent). An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, administered in the leg on an unspecified date (also reported as 23Jun) (Batch/Lot number was not reported) as a single dose for immunisation; also it was reported: the patient received two vaccine doses, one in each leg. The patient remembered one was TRUMENBA but did not remember the other one and did not remember which vaccine went in which leg.  The patient's medical history and concomitant medications were not reported. On an unspecified date (also reported as 23Jun), the patient experienced: blacked out (medically significant), saw "stars" before it went black (non-serious), ears were ringing (non-serious), very light headed (non-serious), soreness in her leg (non-serious), patient received meningococcal group b rlp2086 in the leg (non-serious). The clinical course was reported as follows: The patient's parent reported an adverse experience during the morning. The dates of vaccination was reported as "23Jun." The 18-year-old patient experienced an adverse event when getting the meningococcal group b rlp2086 vaccine in her leg. The patient blacked out for a moment as her eyes rolled up five minutes after receiving that vaccine along with one other shot in the other leg. The patient received two vaccine doses, one in each leg. The patient remembered one was TRUMENBA but did not remember the other one and did not remember which vaccine went in which leg. The doctor said this was a common experience and gave her a Sprite to drink. The patient recovered quickly. The patient's parent reported that the patient was quite thin which may have had an impact. The patient's immediate symptoms were being very lightheaded, saw "stars" before it went black, ears were ringing. Several hours later she was reporting soreness in her leg. Therapeutic measures were taken as a result of blacked out. The clinical outcome of the event, blacked out, was recovered on an unspecified date. The clinical outcome of the remaining events was unknown.  The batch/lot numbers for the vaccine, meningococcal group b rlp2086, were not provided and will be requested during follow up.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Tinnitus, Visual impairment
Clinical narrative: Blacked out; saw "stars" before it went black; Ears were ringing; Very light headed; soreness in her leg; patient received meningococcal group b rlp2086 in the leg; This is a spontaneous report from a contactable consumer (patient's parent). An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, administered in the leg on an unspecified date (also reported as 23Jun) (Batch/Lot number was not reported) as a single dose for immunisation; also it was reported: the patient received two vaccine doses, one in each leg. The patient remembered one was TRUMENBA but did not remember the other one and did not remember which vaccine went in which leg.  The patient's medical history and concomitant medications were not reported. On an unspecified date (also reported as 23Jun), the patient experienced: blacked out (medically significant), saw "stars" before it went black (non-serious), ears were ringing (non-serious), very light headed (non-serious), soreness in her leg (non-serious), patient received meningococcal group b rlp2086 in the leg (non-serious). The clinical course was reported as follows: The patient's parent reported an adverse experience during the morning. The dates of vaccination was reported as "23Jun." The 18-year-old patient experienced an adverse event when getting the meningococcal group b rlp2086 vaccine in her leg. The patient blacked out for a moment as her eyes rolled up five minutes after receiving that vaccine along with one other shot in the other leg. The patient received two vaccine doses, one in each leg. The patient remembered one was TRUMENBA but did not remember the other one and did not remember which vaccine went in which leg. The doctor said this was a common experience and gave her a Sprite to drink. The patient recovered quickly. The patient's parent reported that the patient was quite thin which may have had an impact. The patient's immediate symptoms were being very lightheaded, saw "stars" before it went black, ears were ringing. Several hours later she was reporting soreness in her leg. Therapeutic measures were taken as a result of blacked out. The clinical outcome of the event, blacked out, was recovered on an unspecified date. The clinical outcome of the remaining events was unknown.  The batch/lot numbers for the vaccine, meningococcal group b rlp2086, were not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Haemorrhage, Muscle spasms
Clinical narrative: Extreme bleeding; Cramping; Tightness in chest; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 23Jun2021 (at the age of 18-year-old) at dose 1, single for covid-19 immunisation. Medical history included acne. Family medical history relevant to adverse event was none. Patient did not administer additional vaccines on same date of the Pfizer Suspect. History of all previous immunization with the Pfizer vaccine was not considered as suspect. Patient did not have adverse event following prior vaccinations. Patient did not have prior vaccinations within 4 weeks. Concomitant medication included trimethoprim (TRIMETHOPRIM) at 100mg taken for acne from an unspecified date in Dec2019 and ongoing (Trimethoprim: Patient has been taking this medication for over a year and never had any issues with it. She started it and stopped it and then they had her start it again. It has been sporadic based on her acne). The patient experienced extreme bleeding, cramping, tightness in chest on 24Jun2021 08:00. Patient had an adverse reaction. Patient stated that she had extreme bleeding, cramping and tightness in her chest. Another person came on the line and stated that patient had these symptoms last night and was on the way to the doctor now. Clarified with patient that she was on the way to the hospital. Did not think patient will be receiving the second shot. That person stated that the date of onset of the adverse events was last night, but patient clarified onset date for each event as 24Jun2021. Relevant tests were none. Outcome of the events was not resolved.  Information about lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: bleeding vaginally  four days after receiving her first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable Nurse. This contactable Nurse reported for a 19-year-old female patient that:   A 19-year-old female  patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), dose 1 intramuscular, administered in Arm Right on 22Jan2021 13:30 (Batch/Lot Number: EL9262) as dose 1, single for covid-19 immunization. Medical history included Drug hypersensitivity from an unknown date and unknown if ongoing penicillin allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced bleeding vaginally four days after receiving her first dose of the Pfizer Covid 19 vaccine on 26Jan2021. Nexplanon removal & IUD insertion treatment was received for event bleeding vaginally four days after receiving her first dose of the Pfizer COVID 19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and also since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event "Vaginal haemorrhage" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage Conceived 1 week after the second vaccine.; This is a spontaneous report from a contactable consumer (patient herself). This is a maternal report. A 35-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported at the age of 35-year-old), dose 2 via an unspecified route of administration, administered in arm left on 30Apr2021 08:00 as single for COVID-19 immunisation. The patient had no medical history. The patient concomitant medications were not reported. The patient had no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported), dose 1 via an unspecified route of administration, on an unknown date as single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage conceived 1 week after the second vaccine on 16Jun2021. Doctor confirmed miscarriage at 7.5 weeks (8.5 weeks after second vaccine). The mother reported she became pregnant while taking bnt162b2. The mother was 7 weeks pregnant at the onset of the event. The mother was due to deliver on 27Jan2022. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment medication was received for the event. Since the vaccination, the patient had not tested for COVID-19. The outcome of the event was resolving.   Information on the lot/batch number has been requested. Follow up letter has been generated for further information.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Pallor, Palpitations
Clinical narrative: Heart fluttering; Palpitations; Gray skin pallor; This is a spontaneous report from a contactable nurse. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), via an unknown route of administration on 09Apr2021 single dose for COVID-19 immunization. The patient medical included Psoriatic arthritis, hypermobile joints, chronic fatigue, hypermobile joints, and Iron dextran complex. Patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date was not reported), via an unknown route of administration on 19ar2021 as single dose for covid-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medication included Benzoyl peroxide, clindamycin phosphate (BENZACLIN); Celecoxib (CELEBREX) for arthritis; Loratadine (CLARITIN (LORATADINE)); Secukinumab (COSENTYX); Bisacodyl (DULCOLAX (BISACODYL)); Multivitamin (VITAMINS NOS); Prednisone; Senna acutifolia; Vitamin D3 and Diclofenac Potassium (VOLTAREN). On 30Apr2021, the patient experienced heart fluttering, palpitations, gray skin pallor. Occurs randomly, lasting 20-30 seconds per episode. The clinical outcome of the heart fluttering, palpitations, gray skin pallor was recovered on an unspecified date in 2021.  Follow up needed; Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported Cardiac flutter and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage/IUFD at approximately 17 weeks pregnant.; . The mother was 10 weeks pregnant at the onset of the event; This is a spontaneous report received from a contactable consumer (patient). This is a maternal report. A 31-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0153 at the age of 31-year-old), dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 12:30 as single, dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 12:30 (batch/lot number: EP6955) as single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included sertraline, loratadine taken for an unspecified indication and prenantal. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced miscarriage/IUFD at approximately 17 weeks pregnant on any unknown date Jun2021. The mother reported she became pregnant while taking BNT162B2. The mother was 10 weeks pregnant at the onset of the event. The mother was due to deliver on 07Nov2021. The patient received treatment was dilation and evacuation for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The fetal outcome was intrauterine death. The outcome of the event miscarriage/IUFD at approximately 17 weeks pregnant was resolving. The outcome for the other event was unknown.  Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Fall, Pneumonia staphylococcal
Clinical narrative: He indicates he fell backwards and was intubated (tube in my throat) in the hospital for fourteen days; He indicates he experiences shortness of breath following MRSA pneumonia.; drug ineffective; SARS-COV-2 test positive; He indicates he experiences shortness of breath following MRSA pneumonia.; This is a spontaneous report from a contactable consumer (reporting himself). This 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, 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 included allergies from heck this year and coughing in the call. The patient's concomitant medication was not reported. The patient stated that the patient heard on the news that he would still wear a mask. The patient a few months ago, the patient had SARs-COV-2 (COVID). The patient indicated that he fell backwards and was intubated (tube in throat) in the hospital for fourteen days. On an unknown date, the patient indicated that he experienced shortness of breath following MRSA pneumonia. The patient indicated that he would wait the seven days and continue to wear a mask as he had been in the hospital three times this year. The patient received second dose at noon on the day of reporting. The patient underwent SARs-COV-2 test positive on unspecified date few months ago he had SARs-COV-2 (COVID). The outcome of the events was unknown.  Information about batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: He indicates he fell backwards and was intubated (tube in my throat) in the hospital for fourteen days; He indicates he experiences shortness of breath following MRSA pneumonia.; drug ineffective; SARS-COV-2 test positive; He indicates he experiences shortness of breath following MRSA pneumonia.; This is a spontaneous report from a contactable consumer (reporting himself). This 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, 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 included allergies from heck this year and coughing in the call. The patient's concomitant medication was not reported. The patient stated that the patient heard on the news that he would still wear a mask. The patient a few months ago, the patient had SARs-COV-2 (COVID). The patient indicated that he fell backwards and was intubated (tube in throat) in the hospital for fourteen days. On an unknown date, the patient indicated that he experienced shortness of breath following MRSA pneumonia. The patient indicated that he would wait the seven days and continue to wear a mask as he had been in the hospital three times this year. The patient received second dose at noon on the day of reporting. The patient underwent SARs-COV-2 test positive on unspecified date few months ago he had SARs-COV-2 (COVID). The outcome of the events was unknown.  Information about batch/ lot number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Ear discomfort, Lymphadenopathy, Night sweats, Pain in extremity
Clinical narrative: full blown tinnitus; some ringing in my ear on and off; not much sleep; ear felt full; sore, painful glands neck & base of skull; woke with night sweats; mild arm soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 79-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, in arm right on 26Feb2021 at 17:30 (at the age of 79-years-old) as dose 2, single for covid-19 immunisation. The medical history of the patient included High blood pressure - controlled (hypertension) from an unknown date and unknown if ongoing. The concomitant medications of the patient included levothyroxine sodium (SYNTHROID), losartan, verapamil, colecalciferol (D3) taken for an unspecified indication, start and stop dates were not reported and tumeric. The past drug history of the patient included allergy to penicillin. The patient previously received first dose of BNT162B2(solution for injection, Batch/Lot number: EL9269), via an unspecified route of administration, in arm right on 03Feb2021 at 06:45 PM (at the age of 79-years-old) for COVID-19 immunisation. 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 not been tested with covid-19. The patient experienced mild arm soreness on 27Feb2021 at 21:30, woke with night sweats and sore, painful glands neck & base of skull on 10Mar2021 at 21:30, ear felt full on 12Mar2021 at 21:30, some ringing in my ear on and off and not much sleep on 14Mar2021 at 21:30 and full blown tinnitus on 15Mar2021 at 21:30. The reporter stated that she called her doctor she said there was nothing to be done for it and also stated that tinnitus 24/7; glands sore; ear still wonky (technical term). The events did not result in death or Life threatening or caused/prolonged hospitalization or disabling/incapacitating or congenital anomaly/birth defect. The events are reported as non-serious by the reporter. No treatment was received. The outcome of the events was reported as not resolved.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep deficit, Tinnitus
Clinical narrative: full blown tinnitus; some ringing in my ear on and off; not much sleep; ear felt full; sore, painful glands neck & base of skull; woke with night sweats; mild arm soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 79-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, in arm right on 26Feb2021 at 17:30 (at the age of 79-years-old) as dose 2, single for covid-19 immunisation. The medical history of the patient included High blood pressure - controlled (hypertension) from an unknown date and unknown if ongoing. The concomitant medications of the patient included levothyroxine sodium (SYNTHROID), losartan, verapamil, colecalciferol (D3) taken for an unspecified indication, start and stop dates were not reported and tumeric. The past drug history of the patient included allergy to penicillin. The patient previously received first dose of BNT162B2(solution for injection, Batch/Lot number: EL9269), via an unspecified route of administration, in arm right on 03Feb2021 at 06:45 PM (at the age of 79-years-old) for COVID-19 immunisation. 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 not been tested with covid-19. The patient experienced mild arm soreness on 27Feb2021 at 21:30, woke with night sweats and sore, painful glands neck & base of skull on 10Mar2021 at 21:30, ear felt full on 12Mar2021 at 21:30, some ringing in my ear on and off and not much sleep on 14Mar2021 at 21:30 and full blown tinnitus on 15Mar2021 at 21:30. The reporter stated that she called her doctor she said there was nothing to be done for it and also stated that tinnitus 24/7; glands sore; ear still wonky (technical term). The events did not result in death or Life threatening or caused/prolonged hospitalization or disabling/incapacitating or congenital anomaly/birth defect. The events are reported as non-serious by the reporter. No treatment was received. The outcome of the events was reported as not resolved.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: But got Covid in between those doses; But got Covid in between those doses; This is a spontaneous report from a contactable consumer or other non-HCP (patient).   A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was 1005639239) as DOSE 1, SINGLE for covid-19 immunisation. The patient age at time of vaccination was 54 years. The patient medical history and concomitant medications were none. The patient received her first dose and was supposed to get the second dose on 29Apr2021 but got Covid in between those doses. The reporter reported that, patient received her first dose of Pfizer Biontech Covid Vaccine on 08Apr2021 and was supposed to get the second dose on 29Apr2021 but got Covid in between those doses. The patient asked if she should get the second dose. Pharmacist does not want her to get the second dose but upon speaking with her HCP, she was told that she could get them. The patient kept going to vaccination sites but not one wanted to give her the second dose. The patients original vaccination site where she got the first dose is now closed. The patient underwent lab tests and procedures which included COVID-19 test of positive around 22Apr2021 or 23Apr2021. Outcome of the events but got Covid in between those doses was unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Maternal exposure during pregnancy, Myalgia, Pyrexia
Clinical narrative: Severe diarrhea for 48 hours; fever; muscle aches; chills; Is_pregnant: Yes; This is a spontaneous report from a non-contactable consumer (patient). This is a (maternal or fetus/baby) report.   A 29-year-old pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0180), via an unspecified route of administration, administered in arm left on 22Jun2021 at 12:15 (29-year-old at the time of vaccination) as single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0186), via an unspecified route of administration, administered in arm left on 01Jun2021 (29-year-old at the time of vaccination) as single dose for COVID-19 immunisation and resulted maternal exposure during pregnancy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Jun2021 patient was pregnant and on the same day at 01:00, she experienced severe diarrhea for 48 hours, fever, muscle aches and chills. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. She was 19 weeks pregnant at the onset of the event. Her LMP was on 08Feb2021. The mother was due to deliver on 15Nov2021. Patient did not receive any treatment for the events. Outcome of the event maternal exposure during pregnancy was unknown and was resolving for all other events.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Renal infarct, Thrombosis
Clinical narrative: Renal infarction, or a blood clot in my right kidney; Renal infarction, or a blood clot in my right kidney; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6206) via an unspecified route of administration in left arm on 17Mar2021 at 12:00 (at age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included patient had known allergies to shell fish. Concomitant medication included vitamins NOS (MULTIVITAMINS), daily. Patient did not receive other vaccine in four weeks of vaccination. Medications received within 2 weeks of vaccination included vitamins NOS (MULTIVITAMINS), daily. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, since and post vaccination. On 22Mar2021 at 08:00, patient experienced renal infarction, or a blood clot in right kidney. On 23Mar2021, patient admitted to the emergency room due to event. Treatment received was blood thinners. Outcome of event was recovered.  Follow up attempt is excepted. Further information is requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Extreme brain fog; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 04May2021 (age at vaccination was 32 years and non-pregnant at the time of vaccination) (Batch/Lot Number: EW0179) as dose 1, single for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included norethindrone (norethisterone) (NORETHINDRONE (NORETHISTERONE)) and hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE). The patient was allergic to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. After receiving the vaccine, the patient experienced two weeks of extreme brain fog and fatigue on an unspecified date in May2021. The events resulted to Doctor or other healthcare professional office/clinic visit and considered as medically significant. Prednisone was given as treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Monoplegia
Clinical narrative: leg paralized; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced leg paralized on an unspecified date. The outcome of the event was unknown.  Information regarding the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Rash, Rash pruritic
Clinical narrative: Skin rashes; Extremely itchy; Difficulty of breathing; This is a spontaneous report from a contactable consumer (patients brother). A male patient of an unspecified age received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCIN, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patients brother reported that, until now, 24Jun2021 his brother he is suffering from severe skin rashes that are extremely itchy along with intermittent difficulty of breathing. He was seen by multiple doctors and was prescribed several antihistamine, steroid medication, anti-itch creams but his condition doesn't seem to improve but instead it is get-ting worse. What would be your best recommendation to ensure his safety from overcoming all the severe side effects of the vaccine. They are extremely worrying for his overall health and condition due to the vaccine. Therapeutic measures were taken as a result of skin rashes, extremely itchy, difficulty of breathing. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased, Tachycardia
Clinical narrative: Hugh heart rate and chest pain. Heart rate over 170; Hugh heart rate and chest pain. Heart rate over 170; This is a spontaneous report from a contactable consumer (patient). A 20-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number: EN6208, Expiration Date was not reported), via an unspecified route of administration. administered in left arm on 18Mar2021 12:00 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation at hospital and Other vaccine unknown dose number via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EW0177) as dose number Unknown, single immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. No other vaccine received in four weeks. Any other medications the patient received within 2 weeks of vaccination included Luvox, Lamical. It was reported that, on 27Mar2021 7-10 days after 1st dose, the patient experienced Hugh heart rate and chest pain. Heart rate over 170. The patient underwent lab tests and procedures which included heart rate increased: 170 on 27Mar2021. Metropol was prescribed as treatment for the adverse event. The patient visited emergency room and physician office due to events. Therapeutic measures were taken as a result of hugh heart rate and chest pain. heart rate over 170. The reporter assessed the seriousness as non-serious. The outcome of the events was reported as recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Insomnia, Nausea
Clinical narrative: Severe nausea; Headache; dizziness; can't sleep; This is a spontaneous report received from a contactable consumer or other non hcp (parent). A patient of unspecified age and gender (child) received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot number was not reported (Unable to locate or read the details)), intramuscular, administered in Arm Right on an unspecified date as dose number unknown, single for COVID-19 immunization (administered at Doctor's office/urgent care). The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. Patient did not receive any other vaccine within 4 weeks of vaccination. Patient did not receive any other medications within 2 weeks of vaccination. The patient experienced severe nausea, headache, dizziness and can't sleep (insomnia) on an unspecified date. The mother experience the same events and also reported for her 3 kids. Although 2 were effected much more. The date of start of events for mother was reported to be 23 jun2021 10:00 AM and treated with Avil tablet for sleeplessness. Patients event treatment was not reported. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information on batch/lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, SARS-CoV-2 test, Ventricular extrasystoles
Clinical narrative: Heart flutters; mimicking a pvc; This is a spontaneous report from a contactable consumer (patient). A female patient of 32-year-old age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), second dose on left arm via an unspecified route of administration on 09Apr2021, 09:00AM at unknown dose single for COVID-19 immunization. She was not pregnant at time of vaccination. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), on left arm via an unspecified route of administration on 19Mar2021, 09:00AM for COVID-19 immunization. Vaccine was administered in Doctor's office/urgent care. No medical history reported. Concomitant medication included Levothyroxine (received within 2 weeks of vaccination). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient had been tested positive for covid-19. Patient reported heart flutter and mimicking pvc on 17May2021 (21:00). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Jun2021 Nasal Swab , sars-cov-2 test: negative on 16Jul2020, sars-cov-2 test: negative on 28Oct2020. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of Events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Have been having the heart inflammation that's been going on; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiry date was not reported), via unspecified route of administration on an unspecified date in 2021 (reported as: a couple of weeks ago), as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that a yeah, so patient got the Pfizer vaccine a couple of weeks ago (on an unspecified date in 2021) and patient have been having the heart inflammation that's been going on and patient just noticed that they recommend people that have that the heart inflammation to not get the second shot and stated, patient have had the heart too that have been going on. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: bilateral blood clots in lungs; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, (Batch/Lot number was not reported), dose 1 via an unspecified route of administration in Jan2021 as DOSE 1, SINGLE, via an unspecified route of administration on an Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced bilateral blood clots in lungs after receiving COVID vaccine in January And Feb2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: two patients complain of nose bleeds after receiving the Pfizer vaccine; This is a spontaneous report received from a contactable Pharmacist. This report was received via a sales representative.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that recently two patients complain of nose bleeds after receiving the Pfizer vaccine and wanted to know if that was normal. Its advised that it would be best to bring this up with the medical line. Event took place after use of product. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Epistaxis cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Dyspnoea, Fibrin D dimer
Clinical narrative: D dimer that was not normal; shortness of breath; fever; Blood levels were not normal; headache persisted for 6-8 days; sweats; red circles over body that initially looked like rashes.  The circles (dots, bumps) persist about long contact.  They disappear and look like bruises.; loss of energy; This is a spontaneous report from a contactable consumer or other non-health care professional. A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jun2021, the patient experienced went to urgent care on 23Jun2021 having some symptoms, shortness of breath.They did x-rays was also having a fever. Blood levels were not normal. D dimer that was not normal. States headache persisted for 6-8 days and included sweats. Following the visit to the Urgent Care he was given antibiotics and the shortness of breath improved on 24Jun2021. States he still has a little bit of headache and still has sweats. Also red circles over body that initially looked like rashes. The circles (dots, bumps) persist about long contact.They disappear and look like bruises. She indicates it was not hives. Since Wednesday. Also, indicates loss of energy.Stated odd adverse events. Called yesterday and reported to clinic. She is asking if he should receive second dose? Potential duplicate AE. Sent to emergency room for CT scan of the lungs, which was negative. Therapeutic measures were taken as a result of shortness of breath, headache persisted for 6-8 days and sweats. The adverse events shortness of breath, D dimer that was not normal and fever resulted in emergency room visit. The patient underwent lab tests and procedures which included blood test: normal, computerised tomogram: negative, fibrin d dimer: not normal on 23Jun2021 and x-ray: fever on 23Jun2021. Caller asked that if her partner is fully inoculated should he not receive second dose. The clinical outcome of the events D dimer that was not normal, fever, Blood levels were not normal , red circles over body that initially looked like rashes. The circles (dots, bumps) persist about long contact. They disappear and look like bruises and loss of energy was reported as unknown while for event shortness of breath reported as recovering and for headache persisted for 6-8 day and sweats reported as not recovered.  Information about Lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Headache, Hyperhidrosis, Laboratory test abnormal, Pyrexia
Clinical narrative: D dimer that was not normal; shortness of breath; fever; Blood levels were not normal; headache persisted for 6-8 days; sweats; red circles over body that initially looked like rashes.  The circles (dots, bumps) persist about long contact.  They disappear and look like bruises.; loss of energy; This is a spontaneous report from a contactable consumer or other non-health care professional. A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jun2021, the patient experienced went to urgent care on 23Jun2021 having some symptoms, shortness of breath.They did x-rays was also having a fever. Blood levels were not normal. D dimer that was not normal. States headache persisted for 6-8 days and included sweats. Following the visit to the Urgent Care he was given antibiotics and the shortness of breath improved on 24Jun2021. States he still has a little bit of headache and still has sweats. Also red circles over body that initially looked like rashes. The circles (dots, bumps) persist about long contact.They disappear and look like bruises. She indicates it was not hives. Since Wednesday. Also, indicates loss of energy.Stated odd adverse events. Called yesterday and reported to clinic. She is asking if he should receive second dose? Potential duplicate AE. Sent to emergency room for CT scan of the lungs, which was negative. Therapeutic measures were taken as a result of shortness of breath, headache persisted for 6-8 days and sweats. The adverse events shortness of breath, D dimer that was not normal and fever resulted in emergency room visit. The patient underwent lab tests and procedures which included blood test: normal, computerised tomogram: negative, fibrin d dimer: not normal on 23Jun2021 and x-ray: fever on 23Jun2021. Caller asked that if her partner is fully inoculated should he not receive second dose. The clinical outcome of the events D dimer that was not normal, fever, Blood levels were not normal , red circles over body that initially looked like rashes. The circles (dots, bumps) persist about long contact. They disappear and look like bruises and loss of energy was reported as unknown while for event shortness of breath reported as recovering and for headache persisted for 6-8 day and sweats reported as not recovered.  Information about Lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, X-ray
Clinical narrative: D dimer that was not normal; shortness of breath; fever; Blood levels were not normal; headache persisted for 6-8 days; sweats; red circles over body that initially looked like rashes.  The circles (dots, bumps) persist about long contact.  They disappear and look like bruises.; loss of energy; This is a spontaneous report from a contactable consumer or other non-health care professional. A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jun2021, the patient experienced went to urgent care on 23Jun2021 having some symptoms, shortness of breath.They did x-rays was also having a fever. Blood levels were not normal. D dimer that was not normal. States headache persisted for 6-8 days and included sweats. Following the visit to the Urgent Care he was given antibiotics and the shortness of breath improved on 24Jun2021. States he still has a little bit of headache and still has sweats. Also red circles over body that initially looked like rashes. The circles (dots, bumps) persist about long contact.They disappear and look like bruises. She indicates it was not hives. Since Wednesday. Also, indicates loss of energy.Stated odd adverse events. Called yesterday and reported to clinic. She is asking if he should receive second dose? Potential duplicate AE. Sent to emergency room for CT scan of the lungs, which was negative. Therapeutic measures were taken as a result of shortness of breath, headache persisted for 6-8 days and sweats. The adverse events shortness of breath, D dimer that was not normal and fever resulted in emergency room visit. The patient underwent lab tests and procedures which included blood test: normal, computerised tomogram: negative, fibrin d dimer: not normal on 23Jun2021 and x-ray: fever on 23Jun2021. Caller asked that if her partner is fully inoculated should he not receive second dose. The clinical outcome of the events D dimer that was not normal, fever, Blood levels were not normal , red circles over body that initially looked like rashes. The circles (dots, bumps) persist about long contact. They disappear and look like bruises and loss of energy was reported as unknown while for event shortness of breath reported as recovering and for headache persisted for 6-8 day and sweats reported as not recovered.  Information about Lot/batch number has been requested