chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nervousness
Clinical narrative: nervous; experienced numbness in their shoulder, neck and jaw; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 46-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 26May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nervous, and numbness in their shoulder, neck and jaw. It took 5 hours to go away. The seriousness of the events was non-serious. The outcome of the events was recovered.  Information about lot/ batch number can be requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Investigation
Clinical narrative: pains around left chest area; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Aug2021 at 14:30 (at the age of 38-year-old) (Batch/Lot Number: FC3184) as dose 1, single for COVID-19 immunization. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior to vaccinations received within 4 weeks. No AE(s) following prior vaccinations. Family Medical History Relevant to AE(s) the only thing that he can say was probably blood pressure for his parents. The patient medical history and concomitant medications were none. Patient was calling to report a side effect from the vaccine he took five days ago. Caller clarified vaccine as COVID19 Vaccine. The side effect he felt was pains around left chest area. He doesn't know if it had anything to do with it. He took the shot in his left arm. He had shot and pain in left chest area. It was intense. He first felt it two days after he took the shot and thought it would pass away. It started to get intense. He went to the pharmacy where he got it and they said it could be side effect and for him to go to the emergency room. The Emergency room ran test and gave him Aspirin and some kind of medication that he doesn't know. The next day he felt more better. The shot was given in his left arm. Aspirin: they gave it in the Emergency Room. It was one tablet. He doesn't have the product to provide strength and lot number. He was not currently taking Aspirin and was not on any current medications. Investigations: they did test in the Emergency Room. No further details provided. Event was resulted in emergency room visit. Therapeutic measures were taken for pains around left chest area. The outcome of the event was resolving.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: he has fever that keeps going up right now is 101.7 (unknown units); This is a spontaneous report from a contactable consumer.   A male patient of age 12 (units: unknown ) received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced he has fever that keeps going up right now is 101.7 (unknown units)  on 01Sep2021.  The patient underwent lab tests and procedures which included body temperature: 101.7(unknown units) on 01Sep2021.  The 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: F
Vaccine: COVID19
Symptoms: Chest pain, Investigation, Maternal exposure during pregnancy
Clinical narrative: chest pain; Received her first dose of Comirnaty on 22Apr2021. The patient found out she is 20 weeks and 5 days pregnant as of today; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Apr2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's last period was 10Apr2021. The patient received her first dose of vaccine at first week of pregnancy. The mother was due to deliver on 10Feb2022. On 10May2021 patient went to the emergency department (ED) complaining of chest pain. While in the ER they worked her up and consulted with cardiology but there were no significant findings and it was inconclusive whether the chest pain was caused by vaccine. At the time of reporting the patient's chest pain persisted. The reporter stated that the patient told the her that she was not pregnant when she received vaccine and the she found out she was 20 weeks and 5 days pregnant on the day of reporting, so she must have been pregnant but just did not know it. The patient consulted primary care physician (PCP) who advised patient to wait on getting her second dose of the vaccine. The patient was now seeking advice from the clinic since she was pregnant and was asking if she should receive the 2nd dose. The outcome of chest pain was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Pruritus
Clinical narrative: it kind of itched a little for a week after the second dose; arm got a little sore or a weak feeling; arm got a little sore or a weak feeling; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 10Aug2021 at the age of 45-years-oldas DOSE 2, SINGLE for Covid-19 immunization. Medical history included covid-19 from May2021 to an unknown date She caught covid in May2021 , blood pressure abnormal from an unknown date and unknown if ongoing. She got her first vaccination on 20Jul2021 and second one was 10Aug2021.Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for hypertension from May2021 and ongoing; amlodipine besylate; hydrochlorothiazide taken for blood pressure abnormal from an unspecified start date to 17Aug2021. She is going through some health issues for the past month. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has been tested for Covid-19 Since the vaccination and caught covid in May2021. On an unspecified date, probably a week later after the second dose the patient got a red bump that appeared, it kind of itched a little for a week after the second dose. Then the arm got a little sore or a weak feeling. It was a little red bump as if she just got it. Nothing appeared when she first got it. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Atrial fibrillation, Chills, Diarrhoea
Clinical narrative: afib; So sore/I ached all over but felt better; I could hardly get out of bed; sweating; cold; sick to my stomach; had a splitting headache; so tired; chills; fever; joint pain; nauseated; awful diarrhea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 12Aug2021, as dose 1, single for COVID-19 immunisation. The patient medical history included angioedema for 6 or 7 years from BP medications. The patient concomitant medications were not reported. The patient after woke up in the morning experienced sore/ached all over but felt better, could hardly get out of bed, sweating, cold, sick to stomach, splitting headache, so tired, chills, fever, joint pain, nauseated and awful diarrhea on 22Aug2021. This lasted for 2 days then it started to feel better on Sunday/Monday. Then on Monday night, it ached all over but felt better. On Tuesday, went to the ER because of feeling worse while wokeup and they told that afib on 25Aug2021 but they didn't think it was from the shot and was hospitalized for a week. The patient did not had afib before. The outcome of the event afib was unknown and the other events were recovered on an unknown date of Aug2021. The patient second dose was on 02Sep2021.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Movement disorder, Nasopharyngitis
Clinical narrative: afib; So sore/I ached all over but felt better; I could hardly get out of bed; sweating; cold; sick to my stomach; had a splitting headache; so tired; chills; fever; joint pain; nauseated; awful diarrhea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 12Aug2021, as dose 1, single for COVID-19 immunisation. The patient medical history included angioedema for 6 or 7 years from BP medications. The patient concomitant medications were not reported. The patient after woke up in the morning experienced sore/ached all over but felt better, could hardly get out of bed, sweating, cold, sick to stomach, splitting headache, so tired, chills, fever, joint pain, nauseated and awful diarrhea on 22Aug2021. This lasted for 2 days then it started to feel better on Sunday/Monday. Then on Monday night, it ached all over but felt better. On Tuesday, went to the ER because of feeling worse while wokeup and they told that afib on 25Aug2021 but they didn't think it was from the shot and was hospitalized for a week. The patient did not had afib before. The outcome of the event afib was unknown and the other events were recovered on an unknown date of Aug2021. The patient second dose was on 02Sep2021.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: afib; So sore/I ached all over but felt better; I could hardly get out of bed; sweating; cold; sick to my stomach; had a splitting headache; so tired; chills; fever; joint pain; nauseated; awful diarrhea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 12Aug2021, as dose 1, single for COVID-19 immunisation. The patient medical history included angioedema for 6 or 7 years from BP medications. The patient concomitant medications were not reported. The patient after woke up in the morning experienced sore/ached all over but felt better, could hardly get out of bed, sweating, cold, sick to stomach, splitting headache, so tired, chills, fever, joint pain, nauseated and awful diarrhea on 22Aug2021. This lasted for 2 days then it started to feel better on Sunday/Monday. Then on Monday night, it ached all over but felt better. On Tuesday, went to the ER because of feeling worse while wokeup and they told that afib on 25Aug2021 but they didn't think it was from the shot and was hospitalized for a week. The patient did not had afib before. The outcome of the event afib was unknown and the other events were recovered on an unknown date of Aug2021. The patient second dose was on 02Sep2021.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Drug ineffective, Pyrexia
Clinical narrative: Tests positive for covid approximately 7 months following full vaccination; Tests positive for covid approximately 7 months following full vaccination; Cough; Fever; Chills; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single; received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tests positive for covid approximately 7 months following full vaccination and had cough, fever and chills. It was reported that patient was currently quarantined. The patient underwent lab tests and procedures which included sars-cov-2 test (covid) and showed results Positive on an unknown date in 2021. At the time of this report, the outcome of events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tests positive for covid approximately 7 months following full vaccination; Tests positive for covid approximately 7 months following full vaccination; Cough; Fever; Chills; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single; received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tests positive for covid approximately 7 months following full vaccination and had cough, fever and chills. It was reported that patient was currently quarantined. The patient underwent lab tests and procedures which included sars-cov-2 test (covid) and showed results Positive on an unknown date in 2021. At the time of this report, the outcome of events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Haematochezia
Clinical narrative: possibly blood in my stool; redness; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Sep2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient went to the bathroom past 2 times and reported redness and possibly blood in his stool. Patient received the vaccine at 1 and around 4pm next day he went to the bathroom and it happened again.   As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, patient was asked to consult with doctor/healthcare provider. There is information on Diarrhea but not about "bloody stools" under: 6 ADVERSE REACTIONS. Outcome of the events were unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Rectal haemorrhage, Vaccination site pain
Clinical narrative: Rectal bleeding; Anal incontinence; Vaccination site pain; This is a non-interventional solicited report based on information received by Pfizer from Regulatory Authority (Mfr Control no.: 21K-163-4053241-00) from contactable physician and a non-contactable consumer reported for a 65-Year-Old female patient.   A 65-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly on 11May2021 as dose 2, single (age at vaccination: 65 years) for COVID-19 immunisation; adalimumab (HUMIRA Solution for injection Lot number was not reported) via subcutaneously from an unspecified date to an unspecified date for colitis ulcerative. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly on 16Apr2021 as dose 1, single for COVID-19 immunisation. On an unspecified date 2021, the patient experienced anal incontinence, rectal bleeding, vaccination site pain. It was reported that the patient had leakage and bleeding out the rectum and pain in the arm after covid vaccine with humira. It was unknown if patient was enrolled in a covid-19 vaccine trial. The clinical outcome of the events was not resolved. Causality for HUMIRA(ADALIMUMAB): The reporters causality for the events of leakage and bleeding out the rectum unknown onset, leakage and bleeding out the rectum unknown onset and pain in the arm after covid vaccine with humira (adalimumab) was no reasonable possibility. Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) (TOZINAMERAN), UNKNOWN, UNKNOWN Daily Dose: The reporters causality for the events anal incontinence, rectal bleeding, vaccination site pain was not related.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available in the case , the association between reported Event rectal bleeding is unrelated to the suspect drug. The contribution of patient's age cannot be completely ruled out in the occurrence of the events.    The impact of this report on the benefit/risk profile of the Pfizer drug 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: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chest discomfort, Fatigue, Headache
Clinical narrative: Patient had a rapid covid test on 01Sep2021, results were positive; Patient had a rapid covid test on 01Sep2021, results were positive; worst headache; 101 degree fever; heavy chest; lethargic; achy; extreme fatigue; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This consumer reported that:  A 47-years-old patient of an unspecified gender received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161) dose 2 via an unspecified route of administration on 20Apr2021 at the age of 47 years old as dose 2, single, dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8727) at dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced worst headache, 101 degree fever, heavy chest, lethargic, achy and extreme fatigue. The patient underwent lab tests and procedures which included body temperature: 101 degree on 27Aug2021 and had a rapid covid-19 test results as positive on 01Sep2021. The outcome of the all events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia, Vaccination failure
Clinical narrative: Patient had a rapid covid test on 01Sep2021, results were positive; Patient had a rapid covid test on 01Sep2021, results were positive; worst headache; 101 degree fever; heavy chest; lethargic; achy; extreme fatigue; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This consumer reported that:  A 47-years-old patient of an unspecified gender received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161) dose 2 via an unspecified route of administration on 20Apr2021 at the age of 47 years old as dose 2, single, dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8727) at dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced worst headache, 101 degree fever, heavy chest, lethargic, achy and extreme fatigue. The patient underwent lab tests and procedures which included body temperature: 101 degree on 27Aug2021 and had a rapid covid-19 test results as positive on 01Sep2021. The outcome of the all events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myocarditis, Nervousness
Clinical narrative: myocarditis; nervous; experienced numbness in their shoulder, neck and jaw; This is a spontaneous report from a contactable consumer (Patient's wife) reporting for her husband. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis (medically significant), nervous, experienced numbness in their shoulder, neck and jaw on an unknown date in 2021. Caller stated that she and her husband got their first dose in 26May2021. Both of them are kind of nervous and has experienced numbness in their shoulder, neck and jaw. It took 5 hours to go away. Her husband had developed a heart issue. They were told by their Doctor that it was not normal and it advised not to take the vaccine yet. It has been 99 days since they got their first dose. Caller stated that she lost two friends from COVID and her husband has myocarditis which he didn't have before getting the vaccine. Caller stated that she was just afraid to get the second shot with all of this misinformation circulating out there. The outcome for all events was unknown.   Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Affect lability, Anger, Blood pressure abnormal, Crying, Depression
Clinical narrative: sore arm; crying uncontrollably; rage/ wanted to throw something through the wall; episode of depression; blissfulness; high energy as if he could run a marathon; emotional bouts; dizziness; orthostatic changes from laying in bed to sitting up; pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control; sounds like a neuro reaction; can't stand up; This is a spontaneous report from a contactable Physician. This Physician (Patient's father) reported.  A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection), Lot number was unknown, via unspecified route of administration on 01Sep2021 15:00 as dose 2, single for covid-19 immunization. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, for Covid-19 immunization and experienced only a sore and no other side effects. The patient medical history and concomitant medications were not reported. On 02Sep2021 the patient experienced Sore arm, dizziness, orthostatic changes from laying in bed to sitting up, pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control, sounds like a neuro reaction, can't stand up, crying uncontrollably, rage/ wanted to throw something through the wall, episode of depression, blissfulness, high energy as if he could run a marathon, emotional bouts. On an unspecified date in 2021, the events emotional bouts, high energy as if he could run a marathon, blissfulness, episode of depression, rage/ wanted to throw something through the wall, crying uncontrollably were recovered. At the time of reporting, the outcome of the events can't stand up, sounds like a neuro reaction, dizziness and sore arm were unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during fol-low-up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Emotional disorder, Energy increased, Euphoric mood
Clinical narrative: sore arm; crying uncontrollably; rage/ wanted to throw something through the wall; episode of depression; blissfulness; high energy as if he could run a marathon; emotional bouts; dizziness; orthostatic changes from laying in bed to sitting up; pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control; sounds like a neuro reaction; can't stand up; This is a spontaneous report from a contactable Physician. This Physician (Patient's father) reported.  A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection), Lot number was unknown, via unspecified route of administration on 01Sep2021 15:00 as dose 2, single for covid-19 immunization. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, for Covid-19 immunization and experienced only a sore and no other side effects. The patient medical history and concomitant medications were not reported. On 02Sep2021 the patient experienced Sore arm, dizziness, orthostatic changes from laying in bed to sitting up, pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control, sounds like a neuro reaction, can't stand up, crying uncontrollably, rage/ wanted to throw something through the wall, episode of depression, blissfulness, high energy as if he could run a marathon, emotional bouts. On an unspecified date in 2021, the events emotional bouts, high energy as if he could run a marathon, blissfulness, episode of depression, rage/ wanted to throw something through the wall, crying uncontrollably were recovered. At the time of reporting, the outcome of the events can't stand up, sounds like a neuro reaction, dizziness and sore arm were unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during fol-low-up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Persistent depressive disorder
Clinical narrative: sore arm; crying uncontrollably; rage/ wanted to throw something through the wall; episode of depression; blissfulness; high energy as if he could run a marathon; emotional bouts; dizziness; orthostatic changes from laying in bed to sitting up; pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control; sounds like a neuro reaction; can't stand up; This is a spontaneous report from a contactable Physician. This Physician (Patient's father) reported.  A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection), Lot number was unknown, via unspecified route of administration on 01Sep2021 15:00 as dose 2, single for covid-19 immunization. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, for Covid-19 immunization and experienced only a sore and no other side effects. The patient medical history and concomitant medications were not reported. On 02Sep2021 the patient experienced Sore arm, dizziness, orthostatic changes from laying in bed to sitting up, pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control, sounds like a neuro reaction, can't stand up, crying uncontrollably, rage/ wanted to throw something through the wall, episode of depression, blissfulness, high energy as if he could run a marathon, emotional bouts. On an unspecified date in 2021, the events emotional bouts, high energy as if he could run a marathon, blissfulness, episode of depression, rage/ wanted to throw something through the wall, crying uncontrollably were recovered. At the time of reporting, the outcome of the events can't stand up, sounds like a neuro reaction, dizziness and sore arm were unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during fol-low-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Drug ineffective, Dyspnoea
Clinical narrative: Tested positive for COVID after two doses of Pfizer vaccine; Tested positive for COVID after two doses of Pfizer vaccine; difficulty breathing; cough; The highest my fever got was 100.2.; tightness in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient)  providing investigation results. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: ER8737) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: ER8733) via an unspecified route of administration on 29Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient tested positive for covid after two doses of Pfizer vaccine and difficulty breathing and on unspecified date in 2021, patient experienced tightness in my chest that went on for a long time and on 31Aug2021, patient experienced cough and the highest fever was 100.2. The patient underwent lab tests and procedures which included fever: 100.2 on Tuesday 31Aug2021 and temp normal on Thursday 02Sep2021 and tested positive for COVID on unspecified date in 2021. Therapeutic measures were taken as a result of tightness in my chest, cough, the highest my fever got was 100.2 and difficulty breathing. Patient staying at home and treating symptoms per doctor's instructions and isolating for 10 days from first noted symptoms. Have not gone to the hospital and doctor recommended not going to the hospital unless patient have difficulty breathing. Patient was very happy that patient was vaccinated and very happy it's Pfizer's. As patient thought all along. The reason for patient got the vaccine is not to keep from getting Covid but dying from it. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID after two doses of Pfizer vaccine; Tested positive for COVID after two doses of Pfizer vaccine; difficulty breathing; cough; The highest my fever got was 100.2.; tightness in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient)  providing investigation results. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: ER8737) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: ER8733) via an unspecified route of administration on 29Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient tested positive for covid after two doses of Pfizer vaccine and difficulty breathing and on unspecified date in 2021, patient experienced tightness in my chest that went on for a long time and on 31Aug2021, patient experienced cough and the highest fever was 100.2. The patient underwent lab tests and procedures which included fever: 100.2 on Tuesday 31Aug2021 and temp normal on Thursday 02Sep2021 and tested positive for COVID on unspecified date in 2021. Therapeutic measures were taken as a result of tightness in my chest, cough, the highest my fever got was 100.2 and difficulty breathing. Patient staying at home and treating symptoms per doctor's instructions and isolating for 10 days from first noted symptoms. Have not gone to the hospital and doctor recommended not going to the hospital unless patient have difficulty breathing. Patient was very happy that patient was vaccinated and very happy it's Pfizer's. As patient thought all along. The reason for patient got the vaccine is not to keep from getting Covid but dying from it. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: His wife (me) had tested positive; His wife (me) had tested positive; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of unknown age received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Aug Friday as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 01Sep2021 his COVID PCR test came back positive which was taken on Monday 30Aug2021. His wife had tested positive on Sun 29Aug. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on Sunday 29Aug2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101148635 different patient, same drug and event
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: allergic reaction to the 1st dose; Hives; This is a spontaneous report from a contactable consumer (parent). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 10Aug2021 (Lot Number: EW0181) (at the age of 15-years-old) as dose 1, single for covid-19 immunisation. Medical history was none and there were no concomitant medications. The patient had an allergic reaction to the 1st dose of the vaccine and had hives on 10Aug2021, same day of her dose. The patient did not receive the treatment for the events. The reporter was just wondering as their pediatrician said not to get the 2nd dose. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Incomplete course of vaccination
Clinical narrative: I have a relative that took the first dose and then he fell" and was not able to get to get the second dose; I have a relative that took the first dose and then he fell" and was not able to get to get the second dose; This is a spontaneous report from a contactable consumer reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on an unspecified date as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported that he had a relative that took the first dose and then he fell and was not able to get to get the second dose. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure increased, Blood pressure measurement, Chest pain
Clinical narrative: very, like pain to the point that my arm could not function; affected my blood pressure; was about 130 over 80; I have been experiencing pain in my neck and my shoulder and back; I have been experiencing pain in my neck and my shoulder and back; I have been experiencing pain in my neck and my shoulder and back; Chest pain; it getting ahead to the point in time that I felt like I can possibly; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration on 24Aug2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunisation. Medical history included weight loss. Concomitant medication included metformin taken for weight loss. The patient received first dose of BNT162B2 on 03Aug2021 (Lot no: FC3180) for COVID-19 immunisation. On an unknown date the patient experienced very, like pain to the point that my arm could not function, affected my blood pressure; was about 130 over 80, i have been experiencing pain in my neck and my shoulder and back and chest pain; it getting ahead to the point in time that i felt like i can possibly. The patient reported that she got her second vaccine last Tuesday and noticed after weeks around Thursday and Friday, noticed also a very, like pain to the point that her arm could not function, so her mother checked her blood pressure and it was about 130 over 80 and the worst is it got was on Sunday she took Tylenol extra strength and then on Sunday when she was going to her workplace it helped a bit, she has been experiencing pain in her neck and her shoulder and back and like pain. She reported that the most alarming thing for her is just the chest pain and then it getting ahead to the point in time that she felt like she can possibly pass out. She was just wondering if these were a symptoms that have come across and if it is alarming to go to an urgent care or to an emergency room. Patient was told about the role of Pfizer Medical Information Department. Patient reported that her mom checked her blood pressure on Friday when she started to feel that the symptoms increased and it was 130 over 80 she did not check it today but it seemed like may elevate. She takes vitamins and Metformin for weight loss. The patient reported no treatment and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of affected my blood pressure; was about 130 over 80. The patient underwent lab tests and procedures which included blood pressure measurement: 130/80 mmhg on an unknown date. The outcome of all the events was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: very, like pain to the point that my arm could not function; affected my blood pressure; was about 130 over 80; I have been experiencing pain in my neck and my shoulder and back; I have been experiencing pain in my neck and my shoulder and back; I have been experiencing pain in my neck and my shoulder and back; Chest pain; it getting ahead to the point in time that I felt like I can possibly; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration on 24Aug2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunisation. Medical history included weight loss. Concomitant medication included metformin taken for weight loss. The patient received first dose of BNT162B2 on 03Aug2021 (Lot no: FC3180) for COVID-19 immunisation. On an unknown date the patient experienced very, like pain to the point that my arm could not function, affected my blood pressure; was about 130 over 80, i have been experiencing pain in my neck and my shoulder and back and chest pain; it getting ahead to the point in time that i felt like i can possibly. The patient reported that she got her second vaccine last Tuesday and noticed after weeks around Thursday and Friday, noticed also a very, like pain to the point that her arm could not function, so her mother checked her blood pressure and it was about 130 over 80 and the worst is it got was on Sunday she took Tylenol extra strength and then on Sunday when she was going to her workplace it helped a bit, she has been experiencing pain in her neck and her shoulder and back and like pain. She reported that the most alarming thing for her is just the chest pain and then it getting ahead to the point in time that she felt like she can possibly pass out. She was just wondering if these were a symptoms that have come across and if it is alarming to go to an urgent care or to an emergency room. Patient was told about the role of Pfizer Medical Information Department. Patient reported that her mom checked her blood pressure on Friday when she started to feel that the symptoms increased and it was 130 over 80 she did not check it today but it seemed like may elevate. She takes vitamins and Metformin for weight loss. The patient reported no treatment and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of affected my blood pressure; was about 130 over 80. The patient underwent lab tests and procedures which included blood pressure measurement: 130/80 mmhg on an unknown date. The outcome of all the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Drug ineffective, SARS-CoV-2 test, Taste disorder
Clinical narrative: does not fully have his taste and smell back; does not fully have his taste and smell back; first dose vaccination on 12Aug2021, tested positive on 16Aug2021 and still tested positive to COVID-19 on 30Aug2021; testing positive to COVID-19; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A male patient of unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: unknown), dose 1 via an unspecified route of administration on 12Aug2021 as dose 1, single for COVID-19 immunization. The patient reported that second dose scheduled on 02Sep2021. The patient's medical history and concomitant medications was not reported. On 16Aug2021, the patient experienced testing positive to COVID-19 and reported that still tested positive to COVID-19 on 30Aug2021 and also reported currently, patient did not fully have his taste and smell back and completed his required isolation. On 16Aug2021 and 30 Aug2021 patient underwent lab test and procedure includes COVID-19: SARS-CoV-2 test and result reported as positive. Patient asked if could get the second dose of the Comirnaty vaccine up to 4 days after the scheduled date. The clinical outcome of all events was unknown.   Information about lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Rheumatoid arthritis
Clinical narrative: Lack of drug effect; Rheumatoid arthritis flare up; This is a solicited report from a contactable consumer (Patient) based on the information received by Pfizer  (Mfr. Control No. :21K-163-4055718-00).  A 66-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose intramuscularly, then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021 at single dose intramuscularly for COVID-19 immunisation, methotrexate sodium for Rheumatoid Arthritis, subcutaneous adalimumab (HUMIRA) for Rheumatoid Arthritis, prednisone for an unknown indication; dates were unknown. There was no reported medical history. Concomitant medications were unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial. On unknown dates, the patient experienced rheumatoid arthritis flare ups, he did not think methotrexate sodium was working and he did not think Humira was working. In Feb2021, the patient experienced few rheumatoid arthritis flare ups. On an unknown date, rheumatoid arthritis flare ups resolved. Methotrexate sodium, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and prednisone were also considered suspect. The action taken with methotrexate sodium and HUMIRA was unknown, prednisone was permanently withdrawn on unknow date. The outcome of drug ineffective was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of rheumatoid arthritis flare ups, did not think methotrexate was working and did not think Humira was working was not provided. The reporter's causality for the event(s) of few rheumatoid arthritis flare ups with Humira (Adalimumab) was a reasonable possibility.  The reporter's causality for Rheumatoid arthritis flare up (rheumatoid arthritis) and BNT162B2 was probable  The reporter's assessment of the causal relationship of the events with the methotrexate sodium and of drug ineffective with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Pfizer is a marketing authorization holder of Methotrexate Sodium . This may be a duplicate report if another marketing authorization holder of Methotrexate Sodium has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on data given and temporal association, the event Rheumatoid arthritis is assessed as possibly related to Methotrexate and BNT162B2. The event drug ineffective is possibly related to Methotrexate and unrelated to BNT162B2. 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.