chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neoplasm malignant, Vaccination site discomfort
Clinical narrative: I was diagnosed with a carcinoma; This is a spontaneous report from a non-contactable other Health Professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that, "I got my Pfizer vaccine by the end of March. In May I was diagnosed with a carcinoma. I completed my treatment today. I saw that Pfizer is now doing a booster third shot treatment. I have been under chem and radiation. My company made the recommendation for me to get the booster shot. I propose that I wait a few weeks. They recommended that I call Pfizer. I have already spoken with medical information and safety as well in regards what to get. No one seems to know anything. My question is in the trials what information does Pfizer have to include immunocompromised." Therapeutic measures were taken as a result of the event. The outcome of the event was unknown. The event was considered as serious (medically significant).  No follow-up attempts are possible; information about lot/batch cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event carcinoma) and the suspect vaccine COMIRNATY 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.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: I was diagnosed with a carcinoma; This is a spontaneous report from a non-contactable other Health Professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that, "I got my Pfizer vaccine by the end of March. In May I was diagnosed with a carcinoma. I completed my treatment today. I saw that Pfizer is now doing a booster third shot treatment. I have been under chem and radiation. My company made the recommendation for me to get the booster shot. I propose that I wait a few weeks. They recommended that I call Pfizer. I have already spoken with medical information and safety as well in regards what to get. No one seems to know anything. My question is in the trials what information does Pfizer have to include immunocompromised." Therapeutic measures were taken as a result of the event. The outcome of the event was unknown. The event was considered as serious (medically significant).  No follow-up attempts are possible; information about lot/batch cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event carcinoma) and the suspect vaccine COMIRNATY 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.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neoplasm malignant
Clinical narrative: I was diagnosed with a carcinoma; This is a spontaneous report from a non-contactable other Health Professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that, "I got my Pfizer vaccine by the end of March. In May I was diagnosed with a carcinoma. I completed my treatment today. I saw that Pfizer is now doing a booster third shot treatment. I have been under chem and radiation. My company made the recommendation for me to get the booster shot. I propose that I wait a few weeks. They recommended that I call Pfizer. I have already spoken with medical information and safety as well in regards what to get. No one seems to know anything. My question is in the trials what information does Pfizer have to include immunocompromised." Therapeutic measures were taken as a result of the event. The outcome of the event was unknown. The event was considered as serious (medically significant).  No follow-up attempts are possible; information about lot/batch cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event carcinoma) and the suspect vaccine COMIRNATY 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypoacusis, Tinnitus
Clinical narrative: ears sounds like talking like in a tin can like there was static in head; Ringing in the ears; This is a spontaneous report from a contactable consumer, reporting for herself. A 28-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: FA7485), intramuscularly in the right upper arm on 09Aug2021 at a single dose for covid-19 immunisation. Medical history included on a beta blocker for heart. Concomitant medications included atenolol (MANUAFCTURER UNKNOWN) taken for heart. The patient experienced ears sounds like talking like in a tin can like there was static in head and ringing in the ears on an unspecified date. The events were further described as: after receiving the vaccination dose one, last week, she has been experiencing an adverse effects of ringing in the ears. She described the side effects as better in the morning and almost gone awake when she wakes up but then it progressed throughout the day. She states that it was static like and sounded like she was talking into air or into a tin can and its all day long. She stated that she has been to her doctor and had a CAT scan and that everything came back normal on an unknown date. No therapeutic measures were taken as result of the events. The clinical outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Endocarditis, Myocarditis, Pericarditis
Clinical narrative: Had an issue with the lining of my heart; myocarditis; pericarditis; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that:   A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. On an unspecified date, the patient experienced had an issue with the lining of my heart, myocarditis, pericarditis. Patient asked if she was eligible to take the booster or third shot. Went to pharmacist and had to fill out a form Number 14 says a history of myocarditis, inflammation of the heart, and pericarditis She got myocarditis and pericarditis three weeks ago after her first two COVID-19 shots. Her shots were fine. Is was said that she should not get the booster if she has pericarditis. Clarified her myocarditis and pericarditis have nothing to do with her COVID-19 vaccines. It happened at the Withheld. She was on a lot of blood thinners. Patient was on Colchicine and 3000mg of Aspirin (Intent: treatment). Therapeutic measures were taken as a result of had an issue with the lining of my heart, myocarditis, pericarditis. Events were considered as serious (medically significant). Patient received treatment with Colchicine and 3000mg of Aspirin. The clinical outcome of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Had loss of hearing I still have loss of hearing; I was little upset right now because this morning I still haven't have my hearing and I am not really happy I am, it's very upsetting; This is a spontaneous report from a non-contactable consumer(patient) or other non hcp.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date in 2021, as single dose for covid-19 immunization. Medical history included ongoing hearing loss. concomitant medications were not reported. On an unspecified date in 2021, an hour after patient got shot, patient had loss of hearing and still have loss of hearing this morning. The patient stated that already have hearing loss and then when I got the shot all of a sudden I have, I can't hear. The patient further stated that patient was little upset right now because this morning still haven't have hearing and was not really happy and it's very upsetting. It was stated that the patient would call somebody Monday morning and see what they going to do about this. If this was correct, then patient don't know whether they get the second shot. The clinical outcome of event was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Parkinson's disease
Clinical narrative: Person had the first dose of Pfizer vaccine and now have Parkinson's; This is a spontaneous report from a non-contactable consumer reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH 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 and concomitant medications were not reported. The patient had the first dose of Pfizer vaccine and now have Parkinson's (unspecified date). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Lot of itchy skin and it continued; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications was not reported.  The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. On 11Aug2021 the patient experienced lot of itchy skin and it continued. Therapeutic measures were taken as a result of lot of itchy skin and it continued. Patient stated that: I have taken a Benadryl (treatment) and I don't know if that's enough or do I need to go to see an Urgent Care person.  The clinical outcome of the event was Not recovered.   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: Blindness, Dizziness, Headache
Clinical narrative: Half hour from injection, vision started to become unfocused. Vision off and headache. Lightheaded; Half hour from injection, vision started to become unfocused. Vision off and headache. Lightheaded; Half hour from injection, vision started to become unfocused. Vision off and headache. Lightheaded; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) (Batch/Lot Number: FC3180) via an unspecified route of administration, administered in Arm Left on 14Aug2021 at 10:00 (Age at vaccination: 58-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no concomitant medications. The patient had no allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. On 14Aug2021 at 10:30, The patient experienced half hour from injection, vision started to become unfocused. vision off and headache,Lightheaded. Hospitalization Prolonged was reported as no. Treatment received was reported as no. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Neuralgia, Thrombosis
Clinical narrative: Since getting the second dose, my periods have been essentially nonexistent when they use to be super regular, now I'll randomly have a blood clot fall out; Since getting the second dose, my periods have been essentially nonexistent when they use to be super regular, now I'll randomly have a blood clot fall out; Nerve pain in both arms; This is a spontaneous report from a contactable other hcp. A 24-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, right arm on 02Apr2021 (at the age of 24-years-old) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included allergies to Latex from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not with diagnosed with COVID-19. Since the vaccination, the patient was not with diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, in left arm on 12Mar2021 (at the age of 24-years-old) as single dose for COVID-19 immunisation. It was reported that since getting the second dose on 22Apr2021 the patient's periods had been essentially non-existent when they use to be super regular, now patient randomly have a blood clot fall out. The patient also been experiencing nerve pain in both arms. The patient did not receive any treatment for the events. The patient was not recovered from the events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Blood clot and 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 after receiving the vaccine; tested positive for Covid-19 after receiving the vaccine; This is a spontaneous report from a contactable consumer (Pfizer employee). An adult female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was believed to have received the Pfizer vaccine to completion, but on an unspecified date, patient was still tested positive for Covid-19 after receiving the vaccine. Patient believed she had a sinus infection, but then tested positive for the COVID-19. The events were reported as non-serious by the reporter. This information was received second hand (not from impacted individual) from individual's friend who happens to be a healthcare professional. Since the vaccination, the patient has been tested for COVID-19.The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Confusional state, Cough
Clinical narrative: Loss of consciousness; Tightness in chest; Confusion; Flushing; Diarrhea; Increased BP; Increased Heart rate; Breathing labored and often forgot to labor; Headache; Nausea; Vomiting; Coughing; This is a spontaneous report from a contactable consumer (Patient) reporting for herself.  A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Aug2021 at 14:15 (age at vaccination: 49-year-old and non-pregnant) as DOSE 1, SINGLE for covid-19 immunization at a doctor's office/urgent care. Medical history included mast cell activation syndrome and sjogren's: both from an unknown date and unknown if ongoing. There were no concomitant medications (list of any other medications the patient received within 2 weeks of vaccination: no). Patient had known allergies to latex and penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Aug2021 at 14:15, patient experienced loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing with 50 mg Benedryl, orally. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing was recovered on an unspecified date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Flushing, Headache, Heart rate
Clinical narrative: Loss of consciousness; Tightness in chest; Confusion; Flushing; Diarrhea; Increased BP; Increased Heart rate; Breathing labored and often forgot to labor; Headache; Nausea; Vomiting; Coughing; This is a spontaneous report from a contactable consumer (Patient) reporting for herself.  A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Aug2021 at 14:15 (age at vaccination: 49-year-old and non-pregnant) as DOSE 1, SINGLE for covid-19 immunization at a doctor's office/urgent care. Medical history included mast cell activation syndrome and sjogren's: both from an unknown date and unknown if ongoing. There were no concomitant medications (list of any other medications the patient received within 2 weeks of vaccination: no). Patient had known allergies to latex and penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Aug2021 at 14:15, patient experienced loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing with 50 mg Benedryl, orally. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing was recovered on an unspecified date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Loss of consciousness; Tightness in chest; Confusion; Flushing; Diarrhea; Increased BP; Increased Heart rate; Breathing labored and often forgot to labor; Headache; Nausea; Vomiting; Coughing; This is a spontaneous report from a contactable consumer (Patient) reporting for herself.  A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Aug2021 at 14:15 (age at vaccination: 49-year-old and non-pregnant) as DOSE 1, SINGLE for covid-19 immunization at a doctor's office/urgent care. Medical history included mast cell activation syndrome and sjogren's: both from an unknown date and unknown if ongoing. There were no concomitant medications (list of any other medications the patient received within 2 weeks of vaccination: no). Patient had known allergies to latex and penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Aug2021 at 14:15, patient experienced loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing with 50 mg Benedryl, orally. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing was recovered on an unspecified date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac flutter, Dyspnoea, Electrocardiogram ambulatory, Magnetic resonance imaging
Clinical narrative: severe pains in my heart/squeezing pains in my heart; more heart flutters and palpitations; more heart flutters and palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 23-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 16May2021 (at the age of 23-years-old) as dose 2, single for Covid-19 immunization in other facility. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Since the vaccination, the patient has not been tested for Covid-19. Medical history included depression, anxiety, ptsd (Post-traumatic stress disorder), lactose intolerance, temporal lobe seizures, migraines, known allergies: lithium, Covid-19 (prior to vaccination). Concomitant medication(s) included fluoxetine hydrochloride (PROZAC); vitamin B6; cannabidiol (CBD OIL). The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 25Apr2021 (at the age of 23-years-old) as dose 1, single for Covid-19 immunisation in other facility and experienced trouble focusing and developed a big headache, her eyes had trouble focusing, she was experiencing severe depersonalization, her legs lost function and she could hardly walk, the rest of her body felt weak but kept doing involuntary movements (like hand opening and closing), she struggled to think or talk, it felt like her body was forgetting how to work, she have been having seizures. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has been tested for Covid-19. On 20May2021, the patient experienced severe pains in her heart/squeezing pains in her heart, more heart flutters and palpitations, shortness of breath. It was reported that, four days after her second shot, she experienced severe pains in her heart and shortness of breath, which brought her back to an ER. Since then, she still has squeezing pains in her heart, but not as frequent nor with shortness of breath as much. Yet she does have more heart flutters and palpitations. The heart pains were very regular and intense for about two weeks after the second dose, where she almost went to the ER several times. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart monitor: results unknown and MRI: results unknown on an unspecified date in 2021, nasal Swab: negative on 06Jul2021. Therapeutic measures were taken as a result of the events with IV fluids, benadryl, Reglan. The outcome of the events was not resolved.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: severe pains in my heart/squeezing pains in my heart; more heart flutters and palpitations; more heart flutters and palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 23-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 16May2021 (at the age of 23-years-old) as dose 2, single for Covid-19 immunization in other facility. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Since the vaccination, the patient has not been tested for Covid-19. Medical history included depression, anxiety, ptsd (Post-traumatic stress disorder), lactose intolerance, temporal lobe seizures, migraines, known allergies: lithium, Covid-19 (prior to vaccination). Concomitant medication(s) included fluoxetine hydrochloride (PROZAC); vitamin B6; cannabidiol (CBD OIL). The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 25Apr2021 (at the age of 23-years-old) as dose 1, single for Covid-19 immunisation in other facility and experienced trouble focusing and developed a big headache, her eyes had trouble focusing, she was experiencing severe depersonalization, her legs lost function and she could hardly walk, the rest of her body felt weak but kept doing involuntary movements (like hand opening and closing), she struggled to think or talk, it felt like her body was forgetting how to work, she have been having seizures. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has been tested for Covid-19. On 20May2021, the patient experienced severe pains in her heart/squeezing pains in her heart, more heart flutters and palpitations, shortness of breath. It was reported that, four days after her second shot, she experienced severe pains in her heart and shortness of breath, which brought her back to an ER. Since then, she still has squeezing pains in her heart, but not as frequent nor with shortness of breath as much. Yet she does have more heart flutters and palpitations. The heart pains were very regular and intense for about two weeks after the second dose, where she almost went to the ER several times. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart monitor: results unknown and MRI: results unknown on an unspecified date in 2021, nasal Swab: negative on 06Jul2021. Therapeutic measures were taken as a result of the events with IV fluids, benadryl, Reglan. The outcome of the events was not resolved.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Diarrhoea, Fatigue, Headache, Lymphadenopathy
Clinical narrative: fluttering in chest; headache; fatigue; diarrhea; swollen lymph nodes; This is a spontaneous report from a non-contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (BNT162B2) solution for injection dose 1 (Lot Number: FA7485 expiry date was unknown) via an unspecified route of administration at arm left on 10Aug2021 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing if covid_prior_vaccination: Yes. Concomitant medication(s) included alprazolam (XANAX), vitamin d (vitamin d nos), multivitamins and HRT. No pregnancy at time of Vaccination. The patient had received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Xanax, multivitamins, vitamin D, HRT. Prior to vaccination the patient had diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. Patient had no known allergies. On 11Aug2021 07:00 the patient experienced fluttering in chest, headache, fatigue, diarrhoea and swollen lymph nodes. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date patient had covid_prior_vaccination. No treatment was given. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test
Clinical narrative: fluttering in chest; headache; fatigue; diarrhea; swollen lymph nodes; This is a spontaneous report from a non-contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (BNT162B2) solution for injection dose 1 (Lot Number: FA7485 expiry date was unknown) via an unspecified route of administration at arm left on 10Aug2021 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing if covid_prior_vaccination: Yes. Concomitant medication(s) included alprazolam (XANAX), vitamin d (vitamin d nos), multivitamins and HRT. No pregnancy at time of Vaccination. The patient had received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Xanax, multivitamins, vitamin D, HRT. Prior to vaccination the patient had diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. Patient had no known allergies. On 11Aug2021 07:00 the patient experienced fluttering in chest, headache, fatigue, diarrhoea and swollen lymph nodes. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date patient had covid_prior_vaccination. No treatment was given. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Seizure
Clinical narrative: lost conscious; siziures; Extreme sweats; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on 25Mar2021 at 11:30 at the age of (65-years-old at time of vaccination) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was did not diagnosed with covid-19. Since the vaccination, the patient was did not diagnosed with covid-19. It was reported that on an unspecified date in 2021 the patient experienced extreme sweats, lost conscious, seizures. The patient was not hospitalized due to these events. The patient did not receive any treatment for the events. The patient visited physician office due to these events. The outcome of the events was unknown at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: very high blood sugar in the 450-500 range that persisted for 2.5 weeks; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration, administered in left arm on an unspecified date in May2021 12:00 (at the age of 57-year old), as dose 1, single for COVID-19 immunisation.  Medical history included patient was diabetic and had known allergies to Keflex. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, and did not receive any other vaccines within 4 weeks. The patient received unspecified concomitant medications given within two weeks of vaccination. Another unspecified vaccine with lot number ER87311 was given on the same date of vaccination in May2021 (pending clarification). On 04May2021 12:00, the patient reported that she was diabetic, but the shot gave her very high blood sugar in the 450-500 range that persisted for 2.5 weeks. In other times, her sugar levels were in control. She used a tracking app for her food, so she knew what her numbers were on and verified this with finger sticking. The adverse event resulted in doctor or healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measure taken as a result of the event included additional use of insulin glargine. The outcome of the event was recovered in May2021.  The lot number for BNT162B2, was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid virus after being fully vaccinated with Pfizer vaccine on 3/10/21 and 4/01/21; Tested positive for Covid virus after being fully vaccinated with Pfizer vaccine on 3/10/21 and 4/01/21; This is a spontaneous report from a contactable other hcp (patient).     A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as DOSE 2, SINGLE and first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for covid virus after being fully vaccinated with Pfizer vaccine on an unspecified date in 2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of the event 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 available and a close  association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of COVID-19 and drug ineffective.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: before was a regular layer of Tinnitus,  it got acute ; the acute stage is more worse; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration, administered on 16Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history included ongoing tinnitus and reported that patient already had a mild case of Tinnitus. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via unspecified route of administration, administered on unspecified date as a single dose for covid-19 immunisation. It was reported that patient had second shot on 16Mar2021 of this year and patient previously had a mild case of Tinnitus. After getting the second shot, patient would say within 2-3 days something or maybe its 3-4 days, patient noticed a profound increase in the Tinnitus and patient waited for a long. patient had before was a regular layer of Tinnitus, but this time it got acute now the regular. The patient further reported that if normal layer of Tinnitus, the acute stage it was more worse. Patient went to see an ENT and he doesn't see anything that would had been causing it structurally and now also went see an Audiologist it was nothing that they could do about it. Anyhow patient had been reading that there are people reporting this not in huge amount, what the experiences they occur, or any information can give to patient about expecting it to decrease or patient was concerned about getting a booster shot if that were to be necessary. The patient was not recovered from the event. Outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: I finally did get vaccinated but only out of stupidity; vaccine is only 40% effective; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) 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  get vaccinated but only out of stupidity; vaccine is only 40% effective (drug ineffective) on an unspecified date. The outcome of the event was unknown.  Description of Product Complaint: Consumer stated, "Well here is what to do. I have called here before they took my address yesterday. They were interested in what I had to say unless you people just say you are interested and you, really not. You know I got forensic work for Pfizer because I went to (withheld) grad school for chemistry so, some of the guys in my lab had worked for your company. Anyhow here is the problem I am having now with this vaccine stuff. I finally got, I did get vaccinated but only out of stupidity ok cause I got a question here and here is the question. I took the COVID vaccine (Suspect not clarified hence captured as unspecified vaccine in tab) in Biochemistry the withheld you know with the organic chemistry.  I want to know with the rise in this supposedly delta variant virus. It appears to be rising with the degree of vaccination. Consumer stated, "No I want to inform you and that is the reason I am talking to you that, that Medical Technology Department goes like this 'all lines are busy goodbye' they won't talk. Do not delude yourself that, that department is honest it is not. It is not talking. I will tell you why it is not talking, it is not talking because these really prove that your vaccine is only 40% effective (Further clarification was unknown) but I am not calling about that. What I am asking a general question of drug vaccine safety. Okay, just listen a minute if you have a wrong vaccine, when I used the word wrong that it produces neutralizing antibodies that are not killing the virus. Not the worth is it is not directing the virus to the T- cells and the B- cells. That all it is doing is taking our (Incomplete Sentence). Product Details(LOT#, NDC, UPC, Expiration Date) cannot be probed hence checked unknown in tab.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: She got the first Pfizer Vaccine on 7/23 and then she got COVID; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021, patient got COVID and and she got the antibody infusion on 03Aug2021, so did not recommended to wait 90 days past antibody infusion and to get a dose of COVID vaccine and she already got her first dose and then they did not recommend doing more than 42 for your second dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on 02Aug2021. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She recently developed flu-like symptoms and had a positive COVID-19 test. Fever, headache and nasal congestion are her symptoms; She recently developed flu-like symptoms and had a positive COVID-19 test. Fever, headache and nasal congestion are her symptoms; This is a spontaneous report from a non-contactable consumer (patient) received via a company representative. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date as dose 1, single and  via an unspecified route of administration on 01Mar2021 at the age of 52 years (Lot number and Expiry dates was not reported for both doses) as dose 2, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. It was reported, she recently (at the time of report) developed flu-like symptoms and had a positive COVID-19 test on an unspecified date. Fever, headache, and nasal congestion were reported as her symptoms. Treatment for the event was not reported. Outcome for the event was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she is positive and infected with the delta variant which is the new virus right now; she is positive and infected with the delta variant which is the new virus right now; This is a spontaneous report received from a Pfizer sponsored program from Regulatory Authority. A contactable consumer reported for a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, NDC number, UPC number: Unknown) via an unspecified route of administration on 25Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient would be having the 2nd dose tomorrow that would be 15Aug2021 and unfortunately, she was positive and infected with the delta variant which is the new virus right now (on an unspecified date in 2021) and she was wondering if she could continue getting the Pfizer vaccine tomorrow or she needs to wait for it, she stated that she cannot read it's (lot number) RR what was it SA7485. The events were considered as serious (Medically Significant). The patient underwent lab test and procedure which included Covid-19: Positive, on an unspecified date in 2021. The outcome of the event she is positive and infected with the delta variant which is the new virus right now was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.