chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: anaphylactic reaction; lost consciousness; She did stop breathing and came to right away, she was just out; vomiting; difficulty breathing; Respiratory distress-specifically had difficulty breathing; has a hard time with breathing and running out of breath a lot quicker; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FE3592), via an unspecified route of administration in left arm on 12Sep2021 in the afternoon (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included respiratory issues (already had respiratory issues before). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3181), via an unspecified route of administration in right arm on 08Aug2021 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization and had a little bit of issues with the first one, but she already had respiratory issues before. The patient previously received H1N1 vaccine for Influenza immunization about 10 years ago and ended up in the ICU with neuropathy and myopathy. This was probably when it first came out about 10 years ago and she has complications due to that. The patient's concomitant medications were not reported. Patient received no other vaccines on the same day. The patient experienced anaphylactic reaction, lost consciousness, she did stop breathing and came to right away, she was just out, vomiting, difficulty breathing, respiratory distress-specifically had difficulty breathing; has a hard time with breathing and running out of breath a lot quicker on 12Sep2021. The events resulted in emergency room and physician office visit. It was reported that with second dose, within 15-20 minutes patient experienced vomiting and lost consciousness, difficulty breathing, and the ambulance was then called. She did stop breathing and came to right away, she was just out. She does remember being in the back of the ambulance and going to the hospital and they treated her with medication there to slow things down. Patient was there a couple of hours and discharged home since there was not anything more, they can do for her. She has not improved at all and was still being monitored and has a hard time with breathing and running out of breath a lot quicker. Still has breathing issues. The events required medical intervention. In the emergency room, they treated her to slow things down. Multiorgan involvement included respiratory: Respiratory distress; specifically had difficulty breathing; has a hard time with breathing and running out of breath a lot quicker. Potential anaphylactic reaction was reported to be recovering, but still has breathing issues. Patient was taking medications prior to the event being reported (details not reported). Patient still has not improved at all and is still being monitored. Outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Blood test, Discomfort, Insomnia
Clinical narrative: pins and needle like a neuropathy all over the body like face, hands, toe/little spark throughout my body, sparks like fireworks; could not sleep; tingling in feet, hands, chest, knee, quad/pins and needle like a neuropathy all over the body like face, hands, toe; very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3184), intramuscularly in the left deltoid (reported as left shoulder) on 09Sep2021 at night (at the age of 46-year-old), dose number unknown, single for COVID-19 immunisation. The patient had no medical history and he was healthy. Concomitant medication included multivitamins supplements. On 09Sep2021, at night, the patient had tingling in his feet, hands, chest, knee, and quad. On 10Sep2021, the patient had same problem, so he went to urgent care and the urgent care sent him to the emergency room. The patient had the same symptoms and first day he thought it was blood pressure, but it was not, and they could not figure out what it was. On 10Sep2021 at night he could not sleep, he had pins and needle like a neuropathy all over his body like face, hands, toe. The patient had blood work done and they checked all his level for everything, they check for everything high blood pressure, diabetes, they check his sugar, they check everything and they still could not figure out anything else, so, he talk to some people on social media and they said that they had same thing for 5 months, 6 months. The patient stated he did not want to be in that situation because he was very uncomfortable. The patient was actually taking off of work because there was little spark throughout his body, sparks like fireworks. The patient stated he do not know if anyone else had reported this, but he wanted to make sure what could be done. The patient stated he want to resolve it, he want to get rid off this. The patient stated he was not on the medication for the events yet because the blood work did not show anything, but he did not try to take something to stop what he have. The outcome of the events was unknown.  No follow-up attempts are possible; No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paraesthesia
Clinical narrative: pins and needle like a neuropathy all over the body like face, hands, toe/little spark throughout my body, sparks like fireworks; could not sleep; tingling in feet, hands, chest, knee, quad/pins and needle like a neuropathy all over the body like face, hands, toe; very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3184), intramuscularly in the left deltoid (reported as left shoulder) on 09Sep2021 at night (at the age of 46-year-old), dose number unknown, single for COVID-19 immunisation. The patient had no medical history and he was healthy. Concomitant medication included multivitamins supplements. On 09Sep2021, at night, the patient had tingling in his feet, hands, chest, knee, and quad. On 10Sep2021, the patient had same problem, so he went to urgent care and the urgent care sent him to the emergency room. The patient had the same symptoms and first day he thought it was blood pressure, but it was not, and they could not figure out what it was. On 10Sep2021 at night he could not sleep, he had pins and needle like a neuropathy all over his body like face, hands, toe. The patient had blood work done and they checked all his level for everything, they check for everything high blood pressure, diabetes, they check his sugar, they check everything and they still could not figure out anything else, so, he talk to some people on social media and they said that they had same thing for 5 months, 6 months. The patient stated he did not want to be in that situation because he was very uncomfortable. The patient was actually taking off of work because there was little spark throughout his body, sparks like fireworks. The patient stated he do not know if anyone else had reported this, but he wanted to make sure what could be done. The patient stated he want to resolve it, he want to get rid off this. The patient stated he was not on the medication for the events yet because the blood work did not show anything, but he did not try to take something to stop what he have. The outcome of the events was unknown.  No follow-up attempts are possible; No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Hyperthyroidism
Clinical narrative: hyperthyroid; hair to fall out; This is a spontaneous report from a contactable consumer. This patient reported information for herself and another patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hyperthyroid and hair to fall out on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pericarditis
Clinical narrative: pericarditis per doctor; pain in chest; This is a spontaneous report from a contactable consumer (patient)   A 55-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27Jul2021 15:00 (Batch/Lot Number: fa7484) as single dose (at the age of 55) for covid-19 immunisation. The patient received the first dose at the age of 55, Lot number: ew0173, on 02Jul2021 03:00 PM, left arm. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced pericarditis per doctor on 15Aug2021 12:00, pain in chest on 15Aug2021 12:00. Patient was treated with 600 mg ibuprofen. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. The events outcome was not recovered.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Dysphagia
Clinical narrative: angioedema left upper lip; dysphagia; This is a spontaneous report from a non-contactable physician. A 22-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular on 16Sep2021 at 18:00 (lot number was not reported) as dose number unknown, single for COVID-19 immunization.  Medical history included IDDM (type 1 diabetes mellitus), hypothyroidism and chronic kidney disease (CKD) all from unknown dates. The patient did not have any drug allergies. Concomitant medications included insulin (manufacturer unknown) and levothyroxine sodium (SYNTHROID) both taken for an unspecified indication, start and stop date were not reported.  The patient was not tested for COVID post vaccination. On 16Sep2021, at 20:00 the patient experienced angioedema left upper lip and dysphagia. The event resulted in a visit to the emergency room/urgent care. The patient received prednisone, Benadryl and Pepcid as treatment for the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Lip angioedema cannot be totally excluded.The impact of this report 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Speech disorder, Syncope, Vomiting
Clinical narrative: fainted; body pain; throwing up; fever; couldn't speak; This is a spontaneous report from a contactable consumer(patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: fc3181) via an unspecified route of administration in arm left on 18Aug2021 08:15 (age at vaccination 53 year) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were none. Patient was not pregnant at time of vaccination. No other vaccine in four weeks, no other medications in two weeks and no known allergies. The patient did not had covid prior vaccination and no covid tested post vaccination. On 18Aug2021 20:00, the patient experienced body pain, throwing up, fever, fainted and couldn't speak, that shot killed her. No treatment received for the events. On an unspecified date in 2021, events body pain, throwing up, fever, fainted and couldn't speak, that shot killed her were recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Tinnitus, Vaccination site pain
Clinical narrative: makes my arm hurt; arm is weak; ringing in the left ear; did move around my arm muscle, the left arm where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single (age at vaccination: 63 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had the 1st dose of the Pfizer Covid vaccine 1 month ago and not taken the second dose, because if the 1st dose did this, he is afraid to see what the other one does. On an unspecified date, it was reported that a week after the first dose, my arm is not sore, it did not get sore, is not a pain, like a skin tag, or sharp pain, but it did move around my arm muscle, the left arm where I got the shot, and down my arm, and it makes my arm hurt, my arm is weak, and is not as strong as it used to be. I also had ringing in the left ear sometimes, not all the time and asked are these side effect common and how long will it take for this side effects to go away and how does the body get rid of the vaccine, does it just stay there where you get the shot, because its just affecting my left side. The caller is calling about the Pfizer covid vaccine. The caller needs to speak to someone in charge of all the stuff. The caller had a serious side effect and had some questions and needs to speak to someone. Can Pfizer tell the caller what to do and asked is this a common side effect, had a lot of people reported it. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: urticaria; very large, red, itchy whelps all over her body kind of like an immune response to it and it hasn't stopped.; very large, red, itchy whelps all over her body kind of like an immune response to it and it hasn't stopped.; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0182, Expiry date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 17May2021 10:30 (age at vaccination was 56 years) as dose 2, single for COVID-19 immunization. The patient's medical history included none from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0171, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 20Apr2021 (age at vaccination was 56 years) as dose 1, single for COVID-19 immunization. On 01Jun2021 the patient experienced urticaria and on Jun2021 the patient experienced very large, red, itchy whelps all over her body kind of like an immune response to it and it hasn't stopped. Patient visits Doctor or other healthcare professional office/clinic visit. Patient received treatment as Benadryl and Claritin for the adverse events. Therapeutic measures were taken as a result of urticaria and very large, red, itchy whelps all over her body kind of like an immune response to it and it hasn't stopped. The outcome of the events was not recovered.  Follow-up attempts have been completed and no further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Drug ineffective, Pain, Pyrexia
Clinical narrative: tested positive on a covid-19; tested positive on a covid-19; body is aching / terrible body ache / Pain; vomiting / throwing up; she has lack of appetite; she started to feel like she has a virus infection; Temperature of 101 degrees Fahrenheit / fever like 101 at least; This is a spontaneous report from a contactable nurse (patient herself). A 65-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on 02Sep2021 as dose 1, single for covid-19 immunization (age at vaccination 65-years-old). Medical history included urinary tract infection from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient was tested positive on a covid-19. On 15Sep2021, the patient experienced body is aching / terrible body ache / pain, vomiting / throwing up, she has lack of appetite, she started to feel like she has a virus infection, temperature of 101 degrees fahrenheit / fever like 101 at least. Patient was feeling okay at the moment when she got her injection. She also stated that she has been very healthy, works out regularly, had low weight and no pre-existing conditions aside from UTI that she developed somewhere else. She mentioned that within the last 3 days, she started to feel like she has a virus infection, her body was aching, she had been throwing up (vomiting), and she had lack of appetite. Patient was tested positive on a covid-19 nasal swab test a few days ago. She wanted to know if she can postpone the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine for 5 more days after the recommended 21 days interval from the 1st dose. Clinical outcome of the events was reported as unknown.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Viral infection, Vomiting
Clinical narrative: tested positive on a covid-19; tested positive on a covid-19; body is aching / terrible body ache / Pain; vomiting / throwing up; she has lack of appetite; she started to feel like she has a virus infection; Temperature of 101 degrees Fahrenheit / fever like 101 at least; This is a spontaneous report from a contactable nurse (patient herself). A 65-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on 02Sep2021 as dose 1, single for covid-19 immunization (age at vaccination 65-years-old). Medical history included urinary tract infection from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient was tested positive on a covid-19. On 15Sep2021, the patient experienced body is aching / terrible body ache / pain, vomiting / throwing up, she has lack of appetite, she started to feel like she has a virus infection, temperature of 101 degrees fahrenheit / fever like 101 at least. Patient was feeling okay at the moment when she got her injection. She also stated that she has been very healthy, works out regularly, had low weight and no pre-existing conditions aside from UTI that she developed somewhere else. She mentioned that within the last 3 days, she started to feel like she has a virus infection, her body was aching, she had been throwing up (vomiting), and she had lack of appetite. Patient was tested positive on a covid-19 nasal swab test a few days ago. She wanted to know if she can postpone the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine for 5 more days after the recommended 21 days interval from the 1st dose. Clinical outcome of the events was reported as unknown.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Nausea, SARS-CoV-2 test, Vertigo, Vomiting
Clinical narrative: Episodes of loss of vision in right eye.; Nausea; vomiting for 4 months; vertigo; This is a spontaneous report from a contactable consumer (patient herself).   A 38-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot number: EW0162, expiry date: not reported), via an unspecified route of administration in Arm Left on 07May2021at14:00 (age at vaccination 38 years) as single dose for COVID-19 immunization and second dose via an unspecified route of administration in Arm Right on 03Jun2021 at14:00 (Batch/Lot Number: EW0173) as single dose for COVID-19 immunization. The patient's medical history included penicillin allergy from an unknown date and unknown if ongoing. Patient had COVID prior vaccination. Patient had COVID tested post vaccination via nasal swab. The patient's concomitant medication included lamotrigine (LAMOTRIGINE) taken for an unspecified indication, start and stop date were not reported. On 10May2021 at 12:00, the patient experienced episodes of loss of vision in right eye, nausea, vomiting for 4 months, vertigo.  Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 4 days. Therapeutic measures were taken for all the events (referalls to three doctors prescriptions for vertigo). The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hypotension, Loss of consciousness
Clinical narrative: She passed out and fell; She passed out and fell; blood pressure was low; This is a spontaneous report from a contactable pharmacist. A 23-years-old female patient received first doe of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 14Sep2021 (at age of 23-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had recently received a hepatitis B vaccine for work. Patient participate in annual vaccinations such as the flu vaccine and never had a reaction. On 14Sep2021, she passed out and fell and blood pressure was low. patient administered the epi pen due this incident occurring for the second time back to back. The event she passed out and fell (fall) resulted in visit to emergency room visit. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the event Loss of consciousness and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: went to the ER on 16Sep2021 with an UTI and was diagnosed with COVID-19; went to the ER on 16Sep2021 with an UTI and was diagnosed with COVID-19; went to the ER on 15Sep2021 with an UTI and was diagnosed with COVID-19; She received both doses in the left arm and had complaints of tenderness at the injection site both times; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 65 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included ongoing multiple sclerosis. Additional Information for Other Conditions from seven years and tenderness. Concomitant medication included rituximab (RITUXAN) taken for multiple sclerosis from an unspecified start date and ongoing. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route on left arm of administration Feb2021 on an unspecified date for covid-19 immunization and experienced tenderness, where the needle actually hits, it was a little sore. Patient received both doses in the left arm and had complaints of tenderness at the injection site both times. The day before yesterday 15Sep2021, went to the ER with an UTI and was diagnosed with COVID-19. The patient reported a few months later after vaccination she ask her doctor to do an antibody test; the test showed up negative to any antibodies, they told her she had an autoimmune disease that took away all the antibodies. Patient waited four months to have the antibody test done. She had MS for seven years now; and takes infusions for MS and that was why they were saying she didn't have any antibodies. The ER treated her UTI with antibiotics and it is improving. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date, sars-cov-2 test: positive on 15Sep2021, x-ray: unknown result on an unspecified date. The out come of the event went to the ER on 15Sep2021 with an UTI and was diagnosed with COVID-19 was recovering. Other all events outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, X-ray
Clinical narrative: went to the ER on 16Sep2021 with an UTI and was diagnosed with COVID-19; went to the ER on 16Sep2021 with an UTI and was diagnosed with COVID-19; went to the ER on 15Sep2021 with an UTI and was diagnosed with COVID-19; She received both doses in the left arm and had complaints of tenderness at the injection site both times; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 65 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included ongoing multiple sclerosis. Additional Information for Other Conditions from seven years and tenderness. Concomitant medication included rituximab (RITUXAN) taken for multiple sclerosis from an unspecified start date and ongoing. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route on left arm of administration Feb2021 on an unspecified date for covid-19 immunization and experienced tenderness, where the needle actually hits, it was a little sore. Patient received both doses in the left arm and had complaints of tenderness at the injection site both times. The day before yesterday 15Sep2021, went to the ER with an UTI and was diagnosed with COVID-19. The patient reported a few months later after vaccination she ask her doctor to do an antibody test; the test showed up negative to any antibodies, they told her she had an autoimmune disease that took away all the antibodies. Patient waited four months to have the antibody test done. She had MS for seven years now; and takes infusions for MS and that was why they were saying she didn't have any antibodies. The ER treated her UTI with antibiotics and it is improving. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date, sars-cov-2 test: positive on 15Sep2021, x-ray: unknown result on an unspecified date. The out come of the event went to the ER on 15Sep2021 with an UTI and was diagnosed with COVID-19 was recovering. Other all events outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: I received the Pfizer vaccination in April and I recently have been diagnosed with Bell's Palsy; This is a spontaneous report. A 63-year-old male patient received BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration in left arm in the early afternoon on 23Apr2021 (at the age of 63-years-old) as dose 2, single for COVID-19 immunization in a hospital. Medical history included bell's palsy. Family medical history relevant to events was reported as none. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no concomitant medications/other products reported. Historical vaccination included BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration on 02Apr2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. The patient received the vaccination in Apr2021 and recently had been diagnosed with bell's palsy on 11Sep2021. The patient understood that this might be a possible side effect. The patient requested to provide any information regarding the event. It was reported that there was no investigation assessment and no relevant tests performed. These events didn't led to emergency room and physician's office visit. The outcome of the event was not recovered at the time of report.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: sudden hearing loss; This is a spontaneous report from a contactable consumer (patient's son) via medical information team. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: not provided, expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sudden hearing loss (medically significant). Patient got treated immediately and got his hearing back, it was not as good as it was before. Patient did not have any hearing issues like reporter does. The outcome of the event was recovering.  The lot number for the vaccine was not provided and will be requested during follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Disease recurrence, Dizziness
Clinical narrative: Chills; cold sweat; he experienced a fainting spell/ Micturition syncope; fainting spell after getting the second dose and had a prior history of fainting 3 times in his life time; dizziness/Lightheaded; weakness; This is a spontaneous report from a contactable physician (patient). A male patient of 73-year-old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on Mar2021 (at the age of 72-year-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included history of fainting 3 times in his lifetime prior to getting the vaccine in years past. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: not reported), an unspecified date (at the age of 72-year-old) as DOSE 1, SINGLE for covid-19 immunization and had no reaction. On an unspecified date, 36 hours after getting the second dose, the patient experienced fainting spell. The patient had also experienced dizziness and weakness. The patient felt chills and put on flannel shirt which is unusual in withheld. The next day, patient felt good, but by evening, he had chills again and put flannel shirt on and felt fine.  The patient went to sleep.  Sometime early in the morning around 06:00, he woke up and did not feel bad and decided to go to the bathroom.  The patient urinated and while standing there, the patient felt a cold sweat and felt lightheaded.  The whole thing came about while he was urinating.  There is something called Micturition syncope.  It is not common, but for people who faint, sometimes peeing will make them faint.  The patient wants to know should he get a third dose, or does he disqualify since he fainted. The patient is  not immunocompromised but looking forward to getting the booster dose. The outcome of the event chills was recovered on an unspecified date in 2021, while outcome of all other events was unknown at time of report.   The lot number for the 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Chills; cold sweat; he experienced a fainting spell/ Micturition syncope; fainting spell after getting the second dose and had a prior history of fainting 3 times in his life time; dizziness/Lightheaded; weakness; This is a spontaneous report from a contactable physician (patient). A male patient of 73-year-old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on Mar2021 (at the age of 72-year-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included history of fainting 3 times in his lifetime prior to getting the vaccine in years past. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: not reported), an unspecified date (at the age of 72-year-old) as DOSE 1, SINGLE for covid-19 immunization and had no reaction. On an unspecified date, 36 hours after getting the second dose, the patient experienced fainting spell. The patient had also experienced dizziness and weakness. The patient felt chills and put on flannel shirt which is unusual in withheld. The next day, patient felt good, but by evening, he had chills again and put flannel shirt on and felt fine.  The patient went to sleep.  Sometime early in the morning around 06:00, he woke up and did not feel bad and decided to go to the bathroom.  The patient urinated and while standing there, the patient felt a cold sweat and felt lightheaded.  The whole thing came about while he was urinating.  There is something called Micturition syncope.  It is not common, but for people who faint, sometimes peeing will make them faint.  The patient wants to know should he get a third dose, or does he disqualify since he fainted. The patient is  not immunocompromised but looking forward to getting the booster dose. The outcome of the event chills was recovered on an unspecified date in 2021, while outcome of all other events was unknown at time of report.   The lot number for the 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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Oxygen consumption, Pain, Seizure
Clinical narrative: The next day I experienced 24 short duration (4-5 seconds) full body seizures that I was coherent through; Several days later I felt weight on my chest; The first day after the vaccine I had body aches.; This is a spontaneous report from a contactable consumer(patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FC3182), via an unspecified route of administration, administered in Arm Left on 30Aug2021 12:30 at the age of 38-year-old as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included covid-19 and sustained a severe concussion while snow boarding from Feb2021 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination.  Concomitant medication included lions mane mushroom cognition capsules, fluoxetine. On 31Aug2021, first day after the vaccine patient had body aches. Several days later (Sep2021) he felt weight on chest and his blood oxygen percentage was persistent at 91%. The next day he experienced 24 short duration (4-5 seconds) full body seizures that the patient was coherent through. The event result in doctor or other healthcare professional office/clinic visit and patient did not receive any treatment in response to the events. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy left face; This is a spontaneous report from a contactable physician. A 50-year-Old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single, and via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included hyperlipidaemia, dust mites allergy, shrimp allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient experienced Bell's palsy left face on 08Sep2021. The event resulted in emergency room/physician's office visit. The patient received treatment with prednisone and valacyclovir. The outcome of event was not recovered.  Information on lot/batch number has been requested.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of Bell's palsy left face  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Nephrotic syndrome
Clinical narrative: Development of nephrotic syndrome; This is a spontaneous report from a contactable Physician.  A 26-year-old female patient the second dose of bnt162b2 (BNT162B2), via an unspecified route of administration in Aug2021 (Batch/Lot number was not reported) (at the age of 26-year-old ) as single dose for covid-19 immunisation.  The patient was not pregnant. The patient medical history was none.  No known allergies. Concomitant medications were not reported. On 30Aug2021 the patient developed nephrotic syndrome roughly 2 weeks after the 2nd dose. Renal biopsy showed minimal change disease. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Starting glucocorticoid therapy as treatment. The patient received treatment for the event.  The outcome of he event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and 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.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Malaise, Pyrexia
Clinical narrative: diagnosed with SARS COV-2; he started feeling really ill; his fever at its highest was 101.6 degrees Fahrenheit; lingering cough; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 54-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, administered in Arm Right on 24Aug2021(at the age of 54-year) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history, and no concomitant medications were reported. Reporter states, the patient was diagnosed with COVID on 04Sep2021 after he had symptoms the day before, where he started feeling really ill on 03Sep2021. He says his wife's diagnosis was when she had surgery, within two days she had COVID and he has been taking care of her at home. He says two days after he was taking care of her he started feeling ill so he went Saturday and it was positive when they did the COVID nose swab test. Caller said that they gave him monoclonal antibodies last Monday. He said he has also treated the COVID, they gave him a nose spray but he was not sure what that is called, and he was taking a zinc supplement, and he takes Quercetin 800mg capsules three times a day, and a vitamin pack, and Tylenol to help keep fever down. The patient said his fever at its highest was 101.6 degrees Fahrenheit. He said his Tylenol dosage was the Quick Gels, he takes 400mg at a whack, he does not have the bottle with him but he thinks it is 200mg a piece, and he takes two each time, usually one in the morning and one at night before bed. The patient said he takes Zinc one a time day, Zinc dose unknown. The patient said he feels better now, there were 2-3 days he was getting worried, it seems like a roller coaster ride, but he was much better the last two days, and today is his best day yet. He said his negative test was on 16Sep2021, and the only real symptom he still has was the lingering cough that he has ever so often, and that has eased up a lot on an unknown date in 2021. The patient lab included body temperature: result was 101.6 degrees Fahrenheit on an unspecified date in 2021, COVID nose swab test/COVID test: positive on 04Sep2021 and negative on 16Sep2021. Patient received treatment for all events. On 16Sep2021, the patient recovered from COVID-19 and feeling ill. The event outcome for fever and cough was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.