chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Coeliac disease, Condition aggravated, Diarrhoea, Feeling abnormal
Clinical narrative: had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 02Apr2021 (batch/lot number and expiration date were unknown) as the 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. Relevant medical history included Celiac disease and known allergies to Penicillin; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had no COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination on 02Apr2021. The adverse events did result in a doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a result of all the events. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 02Apr2021 (batch/lot number and expiration date were unknown) as the 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. Relevant medical history included Celiac disease and known allergies to Penicillin; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had no COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination on 02Apr2021. The adverse events did result in a doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a result of all the events. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: I developed an ITP flare after receiving vaccine and my blood platelets dropped to as low as 7000.; I developed an ITP flare after receiving vaccine and my blood platelets dropped to as low as 7000.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer, Batch/Lot number was not reported), via an unspecified route of administration on 15Jan2021 as single dose for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took aspirin (e.c.) and developed allergies (known allergies Aspirin and related products), first dose of bnt162b2 in left arm on 29Dec2020 for covid-19 immunization. The patient developed an ITP (immune thrombocytopenia) flare after receiving vaccine and her blood platelets dropped to as low as 7000 on 22Feb2021. The patient underwent lab tests and procedures which included platelet count: platelets dropped to as low as 7000 on 22Feb2021, nasal swab: negative on an unspecified date. Therapeutic measures (Steroids) were taken as a result of events. No other vaccine in four weeks. No other medications in two weeks. The event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of events was resolving.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, General physical health deterioration, Malnutrition, SARS-CoV-2 test
Clinical narrative: a blood clot in his left arm; possible sepsis; malnourishment; dehydration.; became so weak he slumped down; health has steadily declined; This is a spontaneous report from a contactable consumer (patient's son). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on an unspecified date (batch/lot number was not reported) as 2nd dose, single for covid-19 immunisation.  Medical history included Parkinson's disease, essential thrombocythaemia, and chronic kidney disease which were all under control; and allergies to latex and iodine. The patient's concomitant medications were not reported. On 01Mar2021, shortly after second dose, the patient became so weak, he slumped down and had to be lifted by reporter's uncle, after this incident, his health has steadily declined and now he was hospitalized again on an unspecified date with a blood clot in his left arm, possible sepsis, malnourishment and dehydration. He has Parkinson disease, essential thrombocythemia, chronic kidney disease; however, all were under control until he was vaccinated with the second shot. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for covid-19. The patient underwent lab tests and procedures which included covid test: negative on an unspecified date. Outcome of events was not recovered.  Information about lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Thrombosis
Clinical narrative: a blood clot in his left arm; possible sepsis; malnourishment; dehydration.; became so weak he slumped down; health has steadily declined; This is a spontaneous report from a contactable consumer (patient's son). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on an unspecified date (batch/lot number was not reported) as 2nd dose, single for covid-19 immunisation.  Medical history included Parkinson's disease, essential thrombocythaemia, and chronic kidney disease which were all under control; and allergies to latex and iodine. The patient's concomitant medications were not reported. On 01Mar2021, shortly after second dose, the patient became so weak, he slumped down and had to be lifted by reporter's uncle, after this incident, his health has steadily declined and now he was hospitalized again on an unspecified date with a blood clot in his left arm, possible sepsis, malnourishment and dehydration. He has Parkinson disease, essential thrombocythemia, chronic kidney disease; however, all were under control until he was vaccinated with the second shot. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for covid-19. The patient underwent lab tests and procedures which included covid test: negative on an unspecified date. Outcome of events was not recovered.  Information about lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Influenza like illness, SARS-CoV-2 test
Clinical narrative: Started mild cough, progressed to severe fits with regular difficulty breathing; Started mild cough, progressed to severe fits with regular difficulty breathing; "Flu-like" symptoms; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 31-years-old, via an unspecified route of administration in left arm on 19Apr2021 at 09:00 at 2nd dose, single for COVID-19 immunization. The patient's medical history, concurrent conditions and past drug history were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (VENLAFAXINE) and methylphenidate. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 59267100001) at the age of 31-years-old, via an unspecified route of administration in left arm on 22Mar2021 at 09:00 at 1st dose, single for COVID-19 immunization. The patient received the COVID-19 vaccine in a pharmacy/ drug store. As expected, 2-3 days post-vaccine, on Apr2021, the patient experienced flu-like symptoms. These dissipated but did not resolve completely. Then on 24Apr2021 (also reported as 5-6 days post-vaccine), he started to have mild cough which progressed to severe fits with regular difficulty breathing that has still not stopped 18 days later. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with expectorant, cough suppressant, and antihistamine. The patient underwent lab test and procedures which included nasal swab: negative (SARS-COV-2 (COVID-19), QUALITATIVE, NAA) on 28Apr2021; nasal swab: negative (Bio-Rad SARS-CoV-2 ddPCR) on 30Apr2021; and nasal swab: negative (Binax NOW Coronavirus AG) on 30Apr2021. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in my left ear; This is a spontaneous report from a contactable consumer (reporting for himself). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 15:00 (Batch/Lot Number: Unknown) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included high blood pressure and Allergy: Penicillin. The patient's concomitant medications were not reported. On 01May2021 at 15:00, the patient experienced tinnitus in his left ear. The outcome of the event was not recovered. The event results in doctor or other healthcare professional office/clinic visit. The event was considered serious with disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate, Heart rate increased
Clinical narrative: her pulse ox was 76; shortness of breath; had a high resting heart rate the whole next day, 120-140; a very bad headache; supraventricular tachycardia; lightheaded; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration, administered in left arm on 12Apr2021 10:00 (Batch/Lot Number: Unknown) (at age 36 years old) as single dose for covid-19 immunisation in a pharmacy or drug store. The patient's medical history includes allergies to sulfa drugs. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19 and tested negative post vaccination by nasal swab on 26Apr2021. No other vaccines received within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On an unspecified date, the patient had a high resting heart rate the whole next day, 120-140 and a very bad headache. She got lightheaded once with shortness of breath when driving and her pulse ox was 76 and she had to pull over and breathe deep. She stated maybe it was supraventricular tachycardia. She did not pass out. The patient recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event "pulse ox was 76" with BNT162b2  can not be fully excluded based on the limited information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Supraventricular tachycardia
Clinical narrative: her pulse ox was 76; shortness of breath; had a high resting heart rate the whole next day, 120-140; a very bad headache; supraventricular tachycardia; lightheaded; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration, administered in left arm on 12Apr2021 10:00 (Batch/Lot Number: Unknown) (at age 36 years old) as single dose for covid-19 immunisation in a pharmacy or drug store. The patient's medical history includes allergies to sulfa drugs. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19 and tested negative post vaccination by nasal swab on 26Apr2021. No other vaccines received within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On an unspecified date, the patient had a high resting heart rate the whole next day, 120-140 and a very bad headache. She got lightheaded once with shortness of breath when driving and her pulse ox was 76 and she had to pull over and breathe deep. She stated maybe it was supraventricular tachycardia. She did not pass out. The patient recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event "pulse ox was 76" with BNT162b2  can not be fully excluded based on the limited information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Diarrhoea, Fatigue, Headache, Hypersensitivity
Clinical narrative: Allergic reaction; Allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis); itching; Heavy fatigue; vomiting; diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03May2021 at 08:45 AM (Batch/Lot Number: EW0173) at the age of 40-years-old as 2nd dose, single for COVID-19 immunization at a pharmacy or drug store. The patient had no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included complex regional pain syndrome (CRPS) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lamotrigine (LAMICTAL); both taken for unspecified indications, start and stop dates were not reported (received within 2 weeks of vaccination). The patient previously received the first dose of BNT162B2 (Lot number: ER8729) on 15Apr2021 at 02:15 PM in the left arm for COVID-19 immunization. On 03May2021 at 11:00 AM, the patient experienced allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis). There was extreme pain and burning in addition to itching, and the patient also experienced heavy fatigue, vomiting, diarrhea, and headache. The events resulted in doctor or other healthcare professional office/clinic visit and also emergency room/department or urgent care. The patient was treated with antibiotics for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vomiting
Clinical narrative: Allergic reaction; Allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis); itching; Heavy fatigue; vomiting; diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03May2021 at 08:45 AM (Batch/Lot Number: EW0173) at the age of 40-years-old as 2nd dose, single for COVID-19 immunization at a pharmacy or drug store. The patient had no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included complex regional pain syndrome (CRPS) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lamotrigine (LAMICTAL); both taken for unspecified indications, start and stop dates were not reported (received within 2 weeks of vaccination). The patient previously received the first dose of BNT162B2 (Lot number: ER8729) on 15Apr2021 at 02:15 PM in the left arm for COVID-19 immunization. On 03May2021 at 11:00 AM, the patient experienced allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis). There was extreme pain and burning in addition to itching, and the patient also experienced heavy fatigue, vomiting, diarrhea, and headache. The events resulted in doctor or other healthcare professional office/clinic visit and also emergency room/department or urgent care. The patient was treated with antibiotics for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: the muscles in my face felt weak as if I was having an onset of Bell's Palsy; it was a strange feeling of numbness like a mask covering my face; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 19Feb2021 09:15 as 2nd dose, single for COVID-19 immunization in a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks of vaccination. Not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient previously received the first dose of bnt162b2 on 29Jan2021 09:45 PM (lot number: not provided), at 55 years old in the right arm for COVID 19 immunization. On 19Feb2021 10:45 AM, the patient had muscles in his face felt weak as if was having an onset of Bell's Palsy. The patient reported that he never lost use of his muscles but it was a strange feeling of numbness like a mask covering his face. This lasted for approximately 7 hours. The patient massage and move all his muscles periodically through this event. No treatment was received. The outcome of the events was recovered on 19Feb2021 17:45.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Carbohydrate antigen 15-3, Carcinoembryonic antigen, Cell marker, Neoplasm malignant
Clinical narrative: Individual is Her2 Positive; This is a spontaneous report from a contactable consumer (patient). An adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 25Mar2021 (Batch/Lot number was not reported) as single dose, dose 2 intramuscular on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included aromotase inhibitor anastrozole; hormone therapy of intravenous trastuzumab (HERCEPTIN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The individual was Her2 Positive on an unspecified date and during treatment associated with post chemo there was a change in 2 cancer antigen markers in blood work:  1) Cancer Antigen 15-3 (CA 1503) and 2) Carcinoembryonic Antigen (CEA). Outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, COVID-19, Drug ineffective, Epistaxis, SARS-CoV-2 antibody test
Clinical narrative: herself tested positive for the Covid virus; herself tested positive for the Covid virus; eye sight is not right and my sugar level is super high; eye sight is not right and my sugar level is super high; four blood noses; This is a spontaneous report from a contactable consumer (patient husband). A 49-years-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Mar2021 (at the age of 49-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine on 06Mar2021 and she was scheduled to receive the second dose on 27Mar2021. On 23Mar2021, the patient started experiencing a wet cough. She received a positive PCR test on 25Mar2021 and started having some symptoms. The patient entered the hospital on 26Mar2021 and was admitted for nine days due to low oxygen, in which they gave her remdesivir, plasma, and steroids. She was discharged from the hospital on 03Apr2021. She had ended isolation. She is home now. She still cant smell or taste anything. She retested two weeks later as a follow up and was still positive for Covid. Her "eye sight is not right and my sugar level is super high," in which she believes is from the steroids she was given. She had four blood noses last week, in which she has never had a blood nose in her life. The first week she was very tired, using the bathroom constantly, and had no taste or smell. Her infectious disease doctor told her based upon her treatment regiment, she would need to wait until after 04Jul2021 to get vaccinated and that she would need to get the series again, "as if it was new." She still has not received the second dose of the Pfizer Covid-19 vaccine. She was told she couldn't receive the second shot until 03Jul2021. They advised her to wait 3 months before receiving the vaccine. Also read it is recommended to wait 3 months before getting the vaccine if you received a plasma treatment. These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation. Lastly, the interim considerations state that a prior COVID-19 infection may lower the risk of getting infected again (for a certain amount of time) so if vaccine supply is low, some people with a recent COVID-19 infection may choose to wait to receive their first dose of COVID-19 vaccine. You should talk to your doctor or other health care professional about this. Pfizer is independent of these recommendations. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: herself tested positive for the Covid virus; herself tested positive for the Covid virus; eye sight is not right and my sugar level is super high; eye sight is not right and my sugar level is super high; four blood noses; This is a spontaneous report from a contactable consumer (patient husband). A 49-years-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Mar2021 (at the age of 49-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine on 06Mar2021 and she was scheduled to receive the second dose on 27Mar2021. On 23Mar2021, the patient started experiencing a wet cough. She received a positive PCR test on 25Mar2021 and started having some symptoms. The patient entered the hospital on 26Mar2021 and was admitted for nine days due to low oxygen, in which they gave her remdesivir, plasma, and steroids. She was discharged from the hospital on 03Apr2021. She had ended isolation. She is home now. She still cant smell or taste anything. She retested two weeks later as a follow up and was still positive for Covid. Her "eye sight is not right and my sugar level is super high," in which she believes is from the steroids she was given. She had four blood noses last week, in which she has never had a blood nose in her life. The first week she was very tired, using the bathroom constantly, and had no taste or smell. Her infectious disease doctor told her based upon her treatment regiment, she would need to wait until after 04Jul2021 to get vaccinated and that she would need to get the series again, "as if it was new." She still has not received the second dose of the Pfizer Covid-19 vaccine. She was told she couldn't receive the second shot until 03Jul2021. They advised her to wait 3 months before receiving the vaccine. Also read it is recommended to wait 3 months before getting the vaccine if you received a plasma treatment. These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation. Lastly, the interim considerations state that a prior COVID-19 infection may lower the risk of getting infected again (for a certain amount of time) so if vaccine supply is low, some people with a recent COVID-19 infection may choose to wait to receive their first dose of COVID-19 vaccine. You should talk to your doctor or other health care professional about this. Pfizer is independent of these recommendations. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Very high fever, 103.8 F.; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 14:00 (Batch/Lot number was not reported) as 2nd dose, single (44 years old at the time of vaccine administration) for covid-19 immunisation. Medical history included herpes. Concomitant medication included valaciclovir hydrochloride (VALTREX) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). Historical vaccine included first dose of BNT162B2 on 15Apr2021 for Covid-19 immunization. The patient experienced very high fever 103.8 degrees Fahrenheit on 07May2021 22:30. The patient was treated with ibuprofen and Tylenol. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain, Blood test, Chest pain, Electrocardiogram
Clinical narrative: some in abdomen about three days after vaccination; The pain worsened each day, persistent; EKG was abnormal at urgent care; Developed burning sensation in chest & some in abdomen about three days after vaccination; Developed burning sensation in chest & some in abdomen about three days after vaccination; SHINGRIX administered on 30Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 55 years, on 30Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE, for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for immunization, (lot number: 58160-0823-11), first dose, single, on the left arm from 30Apr2021 to 30Apr2021; other medications the patient received within 2 weeks of vaccination were estradiol;estriol (Estriol/estradiol- 3/0.75mg/ml) and progesterone 75 mg taken for an unspecified indication, start and stop date were not reported. Patient previously took prednisone and erythromycin on unspecified dates for unspecified indications and experienced known allergies. Patient historically received first dose of BNT162B2 (Lot number:EW0162) on the right arm on 17Apr2021 at 09:30 AM for COVID-19 immunisation. Patient developed burning sensation in chest & some in abdomen about three days after vaccination (also reported as 04May2021). The pain worsened each day from 04May2021, persistent, sought advise with a virtual doctor on 02May2021 (as reported). Advised to have EKG ASAP. EKG was abnormal at urgent care on 04May2021. Sent to ER. Patient was seeing a cardiologist for more tests that are scheduled. Patient was not treated for the events. Adverse event resulted in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Patient also underwent lab tests and procedures which includes blood and urine work up on 04Mar2021 with result of kidney, thyroid, liver, cortisol, glucose all optimal. The outcome of the events was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Pain, Product use issue, Urine analysis
Clinical narrative: some in abdomen about three days after vaccination; The pain worsened each day, persistent; EKG was abnormal at urgent care; Developed burning sensation in chest & some in abdomen about three days after vaccination; Developed burning sensation in chest & some in abdomen about three days after vaccination; SHINGRIX administered on 30Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 55 years, on 30Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE, for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for immunization, (lot number: 58160-0823-11), first dose, single, on the left arm from 30Apr2021 to 30Apr2021; other medications the patient received within 2 weeks of vaccination were estradiol;estriol (Estriol/estradiol- 3/0.75mg/ml) and progesterone 75 mg taken for an unspecified indication, start and stop date were not reported. Patient previously took prednisone and erythromycin on unspecified dates for unspecified indications and experienced known allergies. Patient historically received first dose of BNT162B2 (Lot number:EW0162) on the right arm on 17Apr2021 at 09:30 AM for COVID-19 immunisation. Patient developed burning sensation in chest & some in abdomen about three days after vaccination (also reported as 04May2021). The pain worsened each day from 04May2021, persistent, sought advise with a virtual doctor on 02May2021 (as reported). Advised to have EKG ASAP. EKG was abnormal at urgent care on 04May2021. Sent to ER. Patient was seeing a cardiologist for more tests that are scheduled. Patient was not treated for the events. Adverse event resulted in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Patient also underwent lab tests and procedures which includes blood and urine work up on 04Mar2021 with result of kidney, thyroid, liver, cortisol, glucose all optimal. The outcome of the events was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Cardiac stress test normal, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: some in abdomen about three days after vaccination; The pain worsened each day, persistent; EKG was abnormal at urgent care; Developed burning sensation in chest & some in abdomen about three days after vaccination; Developed burning sensation in chest & some in abdomen about three days after vaccination; SHINGRIX administered on 30Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 55 years, on 30Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE, for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for immunization, (lot number: 58160-0823-11), first dose, single, on the left arm from 30Apr2021 to 30Apr2021; other medications the patient received within 2 weeks of vaccination were estradiol;estriol (Estriol/estradiol- 3/0.75mg/ml) and progesterone 75 mg taken for an unspecified indication, start and stop date were not reported. Patient previously took prednisone and erythromycin on unspecified dates for unspecified indications and experienced known allergies. Patient historically received first dose of BNT162B2 (Lot number:EW0162) on the right arm on 17Apr2021 at 09:30 AM for COVID-19 immunisation. Patient developed burning sensation in chest & some in abdomen about three days after vaccination (also reported as 04May2021). The pain worsened each day from 04May2021, persistent, sought advise with a virtual doctor on 02May2021 (as reported). Advised to have EKG ASAP. EKG was abnormal at urgent care on 04May2021. Sent to ER. Patient was seeing a cardiologist for more tests that are scheduled. Patient was not treated for the events. Adverse event resulted in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Patient also underwent lab tests and procedures which includes blood and urine work up on 04Mar2021 with result of kidney, thyroid, liver, cortisol, glucose all optimal. The outcome of the events was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exercise tolerance decreased, Hot flush
Clinical narrative: some in abdomen about three days after vaccination; The pain worsened each day, persistent; EKG was abnormal at urgent care; Developed burning sensation in chest & some in abdomen about three days after vaccination; Developed burning sensation in chest & some in abdomen about three days after vaccination; SHINGRIX administered on 30Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 55 years, on 30Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE, for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for immunization, (lot number: 58160-0823-11), first dose, single, on the left arm from 30Apr2021 to 30Apr2021; other medications the patient received within 2 weeks of vaccination were estradiol;estriol (Estriol/estradiol- 3/0.75mg/ml) and progesterone 75 mg taken for an unspecified indication, start and stop date were not reported. Patient previously took prednisone and erythromycin on unspecified dates for unspecified indications and experienced known allergies. Patient historically received first dose of BNT162B2 (Lot number:EW0162) on the right arm on 17Apr2021 at 09:30 AM for COVID-19 immunisation. Patient developed burning sensation in chest & some in abdomen about three days after vaccination (also reported as 04May2021). The pain worsened each day from 04May2021, persistent, sought advise with a virtual doctor on 02May2021 (as reported). Advised to have EKG ASAP. EKG was abnormal at urgent care on 04May2021. Sent to ER. Patient was seeing a cardiologist for more tests that are scheduled. Patient was not treated for the events. Adverse event resulted in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Patient also underwent lab tests and procedures which includes blood and urine work up on 04Mar2021 with result of kidney, thyroid, liver, cortisol, glucose all optimal. The outcome of the events was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Seizure, Spinal pain, Tremor
Clinical narrative: Not sure if seizure; body muscles started shaking; Pain in lower spine on back; Pain in lower spine on back; This is a spontaneous report from a contactable consumer (patient).   A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 16-years-old), administered in Arm Right on 07May2021 13:00 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunization. Medical history included type 1 diabetic, allergies to severe peanut, "tree but", shellfish. Concomitant medication included insulin lispro (HUMALOG) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 16-years-old), administered in right arm on 16Apr2021 13:00 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. The patient experienced Pain in lower spine on back and body muscles started shaking uncontrollably, not sure if seizure on 08May2021 02:00. No treatment received for the events. The outcome of the events was recovered. The event seizure was considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about lot/batch number is requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Influenza like illness
Clinical narrative: no longer could get an erection; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 24Apr2021 at 09:15 (Batch/Lot number and Expiration date were unknown) as the 2nd dose, single for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. The patient had no medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Apr2021, the patient experienced flu like symptoms. After 48 hours (on 26Apr2021) and when flu like symptoms went away, the patient immediately noticed something else; he no longer could get an erection. He had never had an issue ever in life until 48 hours after his second injection and still 2 weeks later, he could not get an erection, which was considered serious as it resulted in disability. The adverse events (AEs) did result in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the AEs. The patient recovered from the event "flu like symptoms" on 26Apr2021, while he was not recovered from the event "no longer could get an erection."  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Headache, Paraesthesia
Clinical narrative: pericarditis; headache; fever; having trouble breathing; chest pain; tingling down his arms; This is a spontaneous report from a contactable consumer. An 18-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 04May2021 at 16:00 (Batch/Lot Number: ER8736) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior to vaccination and was not tested post vaccination. The patient experienced Pericarditis, headache, fever, having trouble breathing, chest pain and tingling down his arms all on 06May2021. It was reported that the patient had all the normal reactions to a significant extent, the headache, the fever, etc. But two nights after the vaccination he was having trouble breathing, he had chest pain, and tingling down his arms. The next day, patient was taken to urgent care and was diagnosed with pericarditis. The patient underwent lab tests and procedures which included EKG (electrocardiogram): pericarditis on 06May2021 (EKG showing Pericarditis and 10 days  of medication). Therapeutic measures were taken as a result of all the events. The outcome of all the events was unknown.