chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Chills, Fatigue, Illness, Insomnia
Clinical narrative: No motivation; Severe fatigue/always felt tired and it keep coming back; Some tiredness; trouble sleeping; Felt quite sick; Chills; she keeps falling asleep; This is a spontaneous report received from contactable consumer (patient). This 67-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On an unspecified date after dose 2 of BNT162B2 the patient experienced chills, some tiredness, felt quite sick. This was resolved short after. She had experienced severe fatigue after a couple of weeks after getting her second dose. She exercised regularly 5 days a week but right now she just sat down and kept falling asleep. Sometimes she also had some trouble sleeping. She also had no motivation, always felt tired and it kept coming back and was "driving her crazy." The outcomes of chills, some tiredness, and felt quite sick were resolved. The outcomes of severe fatigue, kept falling asleep, trouble sleeping, no motivation and felt tired were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: No motivation; Severe fatigue/always felt tired and it keep coming back; Some tiredness; trouble sleeping; Felt quite sick; Chills; she keeps falling asleep; This is a spontaneous report received from contactable consumer (patient). This 67-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On an unspecified date after dose 2 of BNT162B2 the patient experienced chills, some tiredness, felt quite sick. This was resolved short after. She had experienced severe fatigue after a couple of weeks after getting her second dose. She exercised regularly 5 days a week but right now she just sat down and kept falling asleep. Sometimes she also had some trouble sleeping. She also had no motivation, always felt tired and it kept coming back and was "driving her crazy." The outcomes of chills, some tiredness, and felt quite sick were resolved. The outcomes of severe fatigue, kept falling asleep, trouble sleeping, no motivation and felt tired were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Axillary mass, Chills, Haemorrhage, Hypoaesthesia, Ligament sprain
Clinical narrative: After first Pfizer dose, I was just feeling really tired. After the second dose, around that afternoon/evening I started feeling my mouth feeling weird. The next day I saw blisters filled with yellow/whiteish puss in my tongue. I went to the ER later i felt a lump under left shoulder while showering. On 28 MAY 3 AM I suddenly felt my face feeling numb and tingly along with my legs. Mind you I have been in the field emplacing howizters for the past few days in a field exercise. I also jammed my finger on an 80 lb metal bar on 26 MAY and got my finger poked with a hot device that also drained the blood after getting an xray. I called medical ER  at 242 and spoke to Dr.(?) Doctor did not give me his name spelling after I asked for the spelling and he told me that I could always come in to the ER. I told him whether the finger pricking and blooding draining could cause the left facial numbness and legs tingleness. He said no so i am now assuming it is an adverse side effect. I am a smart guy have bachelors in journalism but right now I cannot concentrate and filling out htis form hastily just i case the effects get worse and I have to go to hospital er. Talking to the Dr. (?) was harder than normal and he asked if my breathing was normal, I said i am breathing heavily, which I did not have much control over. He said breathe normally and I will be better from the tingliness. I can write well I am a journalism major but this is hard to write for me . I am also feeling chills and I am also not feeling well. I was able to get this link from my local online meeting and I am glad I can contribute to the research and science in general. I wish the doctor had tested me for possible problems when I had an adverse effect from the first vaccine but the doctor told me to come back if the "viral infection" gets worse after I breathe normal. I did take a PT test and my 2 mile run time increased and it was much harder to run than the 2 mile run. Time went up by at least 3 minutes.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Limb injury, Malaise, Paraesthesia, Pustule, Respiration abnormal
Clinical narrative: After first Pfizer dose, I was just feeling really tired. After the second dose, around that afternoon/evening I started feeling my mouth feeling weird. The next day I saw blisters filled with yellow/whiteish puss in my tongue. I went to the ER later i felt a lump under left shoulder while showering. On 28 MAY 3 AM I suddenly felt my face feeling numb and tingly along with my legs. Mind you I have been in the field emplacing howizters for the past few days in a field exercise. I also jammed my finger on an 80 lb metal bar on 26 MAY and got my finger poked with a hot device that also drained the blood after getting an xray. I called medical ER  at 242 and spoke to Dr.(?) Doctor did not give me his name spelling after I asked for the spelling and he told me that I could always come in to the ER. I told him whether the finger pricking and blooding draining could cause the left facial numbness and legs tingleness. He said no so i am now assuming it is an adverse side effect. I am a smart guy have bachelors in journalism but right now I cannot concentrate and filling out htis form hastily just i case the effects get worse and I have to go to hospital er. Talking to the Dr. (?) was harder than normal and he asked if my breathing was normal, I said i am breathing heavily, which I did not have much control over. He said breathe normally and I will be better from the tingliness. I can write well I am a journalism major but this is hard to write for me . I am also feeling chills and I am also not feeling well. I was able to get this link from my local online meeting and I am glad I can contribute to the research and science in general. I wish the doctor had tested me for possible problems when I had an adverse effect from the first vaccine but the doctor told me to come back if the "viral infection" gets worse after I breathe normal. I did take a PT test and my 2 mile run time increased and it was much harder to run than the 2 mile run. Time went up by at least 3 minutes.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tongue blistering
Clinical narrative: After first Pfizer dose, I was just feeling really tired. After the second dose, around that afternoon/evening I started feeling my mouth feeling weird. The next day I saw blisters filled with yellow/whiteish puss in my tongue. I went to the ER later i felt a lump under left shoulder while showering. On 28 MAY 3 AM I suddenly felt my face feeling numb and tingly along with my legs. Mind you I have been in the field emplacing howizters for the past few days in a field exercise. I also jammed my finger on an 80 lb metal bar on 26 MAY and got my finger poked with a hot device that also drained the blood after getting an xray. I called medical ER  at 242 and spoke to Dr.(?) Doctor did not give me his name spelling after I asked for the spelling and he told me that I could always come in to the ER. I told him whether the finger pricking and blooding draining could cause the left facial numbness and legs tingleness. He said no so i am now assuming it is an adverse side effect. I am a smart guy have bachelors in journalism but right now I cannot concentrate and filling out htis form hastily just i case the effects get worse and I have to go to hospital er. Talking to the Dr. (?) was harder than normal and he asked if my breathing was normal, I said i am breathing heavily, which I did not have much control over. He said breathe normally and I will be better from the tingliness. I can write well I am a journalism major but this is hard to write for me . I am also feeling chills and I am also not feeling well. I was able to get this link from my local online meeting and I am glad I can contribute to the research and science in general. I wish the doctor had tested me for possible problems when I had an adverse effect from the first vaccine but the doctor told me to come back if the "viral infection" gets worse after I breathe normal. I did take a PT test and my 2 mile run time increased and it was much harder to run than the 2 mile run. Time went up by at least 3 minutes.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Full blood count, Musculoskeletal chest pain
Clinical narrative: c/o chest pain began 1 day (may 26) after2nd pfizer vaccination (May 25). Patient came to ER on 5/27. C/o chest pain. Physical exam shows chest wall Tenderness to palpation.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: c/o chest pain began 1 day (may 26) after2nd pfizer vaccination (May 25). Patient came to ER on 5/27. C/o chest pain. Physical exam shows chest wall Tenderness to palpation.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment elevation, Immunoglobulin therapy
Clinical narrative: c/o chest pain began 1 day (may 26) after2nd pfizer vaccination (May 25). Patient came to ER on 5/27. C/o chest pain. Physical exam shows chest wall Tenderness to palpation.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Magnetic resonance imaging heart, Myocarditis, Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: c/o chest pain began 1 day (may 26) after2nd pfizer vaccination (May 25). Patient came to ER on 5/27. C/o chest pain. Physical exam shows chest wall Tenderness to palpation.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Ventricular hypokinesia, Vomiting
Clinical narrative: c/o chest pain began 1 day (may 26) after2nd pfizer vaccination (May 25). Patient came to ER on 5/27. C/o chest pain. Physical exam shows chest wall Tenderness to palpation.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red, intense itching at injection site (3-4? radius).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Nausea
Clinical narrative: I received my menstruation 9 days before it was planned. It is heavy and I also have slight nausea. It was unexpected and I would like to know if the vaccine correlates to the early menstruation.  I am not on any birth control.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Nausea, vomiting and diarrhea starting around 2am and lasting until around 6am. Later that same day (Tuesday) I had fever, some nausea, and fatigue. My arm was sore and swollen starting Monday night. By Wednesday morning I developed a red rash that is itchy. As of today (Friday early am), the rash has grown larger and more itchy, but the swelling has gone down. All other symptoms disappeared by Wednesday morning.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash erythematous, Vomiting
Clinical narrative: Nausea, vomiting and diarrhea starting around 2am and lasting until around 6am. Later that same day (Tuesday) I had fever, some nausea, and fatigue. My arm was sore and swollen starting Monday night. By Wednesday morning I developed a red rash that is itchy. As of today (Friday early am), the rash has grown larger and more itchy, but the swelling has gone down. All other symptoms disappeared by Wednesday morning.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypertension, Malaise
Clinical narrative: wasn't feeling well; intensified her illness; blood pressure and it was elevated; This is a spontaneous report from a contactable consumer (patient's husband). A 48-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient went for her second dose of BNT162B2 yesterday (26Apr2021). She wasn't feeling well a couple days prior to going and she wasn't feeling well yesterday. The vaccination facility checked her blood pressure and it was elevated so they did not administer the vaccine. The patient's husband did not think her illness came from the vaccine but thought it may have intensified her illness. The patient's husband wanted to know if the patient could still receive the dose at 4 or 5 weeks after being evaluated by her doctor. The outcomes of wasn't feeling well, elevated blood pressure, and intensified illness were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: severe headache; feeling fatigued; sore on the same side of the vaccine; This is a spontaneous report from a contactable consumer (patient). This 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 22Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported developing a severe headache, feeling fatigued, and sore on the same side of the vaccine. He inquired how long the side effects would last. The clinical outcomes of severe headache, feeling fatigued, and sore on the same side of the vaccine were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pneumonia, Pyrexia, X-ray
Clinical narrative: I have pneumonia; She developed a cough last Sunday; she had a fever once; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patent experienced having pneumonia on an unspecified date and is due to receive her second injection of the Pfizer covid-19 vaccine today. The pneumonia was being treated with Rocephin and cefdinir. The patient was trying to decide whether to get her second injection today or delay it for a period of time due to having pneumonia. She does plan to ask her physician for a recommendation. It was reported that the patient developed a cough last Sunday but no fever. The patient has a fever once at 100 degrees. She went to her doctor and the doctor listened to her lungs and did an x-ray which confirmed she had pneumonia. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Eye pain, Fatigue, Feeling hot
Clinical narrative: Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the touch (no fever); eye pain; exhaustion; vertigo; mild nausea; Left temple throbbing and pulsating/headache; Heart pounding; This is a spontaneous report from a contactable consumer (patient).  A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:30 (Batch/Lot Number: ER8736), age at vaccination of 40-years-old, as single dose, for covid-19 immunisation.  The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination.    There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine headache everyday, neck pain, dizziness, head and neck hot to the touch (no fever), eye pain, exhaustion, some vertigo and mild nausea, left temple throbbing and pulsating, heart pounding an fluttering occasionally, all on 30Apr2021 at 1730. No treatments were give for the events. Facility where the most recent COVID-19 vaccine was administered: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 10May2021. The patient had not recovered from the events. Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea, Neck pain, Palpitations
Clinical narrative: Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the touch (no fever); eye pain; exhaustion; vertigo; mild nausea; Left temple throbbing and pulsating/headache; Heart pounding; This is a spontaneous report from a contactable consumer (patient).  A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:30 (Batch/Lot Number: ER8736), age at vaccination of 40-years-old, as single dose, for covid-19 immunisation.  The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination.    There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine headache everyday, neck pain, dizziness, head and neck hot to the touch (no fever), eye pain, exhaustion, some vertigo and mild nausea, left temple throbbing and pulsating, heart pounding an fluttering occasionally, all on 30Apr2021 at 1730. No treatments were give for the events. Facility where the most recent COVID-19 vaccine was administered: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 10May2021. The patient had not recovered from the events. Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the touch (no fever); eye pain; exhaustion; vertigo; mild nausea; Left temple throbbing and pulsating/headache; Heart pounding; This is a spontaneous report from a contactable consumer (patient).  A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:30 (Batch/Lot Number: ER8736), age at vaccination of 40-years-old, as single dose, for covid-19 immunisation.  The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination.    There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine headache everyday, neck pain, dizziness, head and neck hot to the touch (no fever), eye pain, exhaustion, some vertigo and mild nausea, left temple throbbing and pulsating, heart pounding an fluttering occasionally, all on 30Apr2021 at 1730. No treatments were give for the events. Facility where the most recent COVID-19 vaccine was administered: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 10May2021. The patient had not recovered from the events. Information on the lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Loss of consciousness
Clinical narrative: Heart arrhythmia (fluttering); I lost consciousness; This is a spontaneous report from a non-contactable consumer reporting for himself  A 56-year-old male patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8731) on 17Apr2021 at single dose via an unspecified route of administration  for COVID-19 immunization. The patient did not have relevant medical history. Concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: ER8730) on 27Mar2021 on arm left. On an unspecified date after vaccination the patient reported he had  lost consciousness in the morning right after exercise while experiencing arrhythmia. No treatment received for the events. At the time of the reporting the patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Rhinorrhoea, SARS-CoV-2 test, Vertigo
Clinical narrative: hearing loss; my nose started to run non stop; type of vertigo symptom's; This is a spontaneous report from a contactable other HCP (patient herself).  This 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number el3249), via an unknown route, on 01Feb2021 (at the age of 76-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided) on unknown date for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included lisinopril and atorvastatin. The patient received the last shot on 01Feb2021. The next day ''my nose started to run nonstop''. The runny nose lasted for about 6 days. The next thing that happened was a type of vertigo symptom's that lasted for 4 days. On 12Feb2021 ''I woke up and could not hear out of my left ear''. The hearing loss was trying to come back but did not. The events required a physician office visit. She was treated for the events. On 23Mar2021, the patient performed a hearing test, but results were not provided. On 12Apr2021, a nasal swab was done and resulted negative. The patient had recovered from 'my nose started to run non stop' on 08Feb2021 and from 'type of vertigo symptom's' on 06Feb2021. The outcome of 'hearing loss' was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Tinnitus in both ears; Heavy fever; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 11May2021 14:15 (at the age of 26-years-old) as 2nd dose, single for COVID-19 immunisation. The vaccine was administered at healthcare facility. The patient did not receive other vaccines in four weeks. The patient received the first dose of BNT162b2 on an unspecified date. The patient's medical history concomitant medications were not reported. The patient had no known allergies. On 12May2021 at 07:45 the patient experienced sudden tinnitus in both ears after heavy fever. The events were reported as serious due to disability. The patient did not receive treatment for events. Prior to vaccination the patient was not diagnosed with COVID-19 and he has not been tested for COVID-19. The events were not resolved.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, Bladder hypertrophy, Culture, Renal function test, SARS-CoV-2 test negative
Clinical narrative: Swollen bladder and thickening of the bladder suddenly on 07May2021.; Swollen bladder and thickening of the bladder suddenly on 07May2021.; This is a spontaneous report from a contactable consumer. A 46-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 (at the age of 46-years-old) as a single dose for covid-19 immunization. Medical history included, hypersensitivity with bees, peppers (bell/Jalepeno). Past drug included levaquin. Concomitant medication(s) included omeprazole 40 mg daily. The patient was not pregnant at the time of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration on left arm in Mar2021 09:00 at single dose for covid-19 immunization. The patient had no other vaccine within four weeks prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19, device Date is 12May2021. On 07May2021 16:00, the patient was diagnosed with a swollen bladder and thickening of the bladder suddenly and resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit and the patient was hospitalized with the duration of 3 days with no prolonged hospitalization. Elevated WBC and kidney enzymes but no other traditional symptoms of a UTI. No bacteria growth in culture. Doctor reports the thickening happened in the last month or so. The patient underwent lab tests and procedures which included white blood cell count: elevated, sars-cov-2 test: negative on 07May2021 Rapid SARS Cov 2, renal function test: elevated, culture: no bacteria growth, no other traditional symptoms of a UTI. The patient received treatment for events with IV antibiotics. Outcome of the events was recovering.  Follow-up attempts are needed. Further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Swollen bladder and thickening of the bladder suddenly on 07May2021.; Swollen bladder and thickening of the bladder suddenly on 07May2021.; This is a spontaneous report from a contactable consumer. A 46-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 (at the age of 46-years-old) as a single dose for covid-19 immunization. Medical history included, hypersensitivity with bees, peppers (bell/Jalepeno). Past drug included levaquin. Concomitant medication(s) included omeprazole 40 mg daily. The patient was not pregnant at the time of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration on left arm in Mar2021 09:00 at single dose for covid-19 immunization. The patient had no other vaccine within four weeks prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19, device Date is 12May2021. On 07May2021 16:00, the patient was diagnosed with a swollen bladder and thickening of the bladder suddenly and resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit and the patient was hospitalized with the duration of 3 days with no prolonged hospitalization. Elevated WBC and kidney enzymes but no other traditional symptoms of a UTI. No bacteria growth in culture. Doctor reports the thickening happened in the last month or so. The patient underwent lab tests and procedures which included white blood cell count: elevated, sars-cov-2 test: negative on 07May2021 Rapid SARS Cov 2, renal function test: elevated, culture: no bacteria growth, no other traditional symptoms of a UTI. The patient received treatment for events with IV antibiotics. Outcome of the events was recovering.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated, Fatigue, Feeling abnormal, Muscular weakness
Clinical narrative: "feels like I am having an autoimmune flare up, I feel so fatigued and crappy; "feels like I am having an autoimmune flare up, I feel so fatigued and crappy; "feels like I am having an autoimmune flare up, I feel so fatigued and crappy; "feels like I am having an autoimmune flare up, I feel so fatigued and crappy; cannot lift her head up; scared; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Apr2021 as single dose for covid-19 immunisation. First dose was administered on 06Apr2021. Medical history included rheumatoid arthritis, ongoing Sjogren's, ongoing epilepsy, ongoing autoimmune disorder. The patient's concomitant medications were not reported. The patient experienced "feels like i am having an autoimmune flare up, i feel so fatigued and crappy'' on May2021, cannot lift her head up on May2021, scared on May2021. Her doctor prescribed a medrol dose pack to take orally, 4mg po. "I was suppose to take 6 of the pills last night and I only took 2 pills." Caller reported that sometimes the steroids helps with the fatigue from her autoimmune disorder and that is how her physician treats it. Caller reported that she started taking the Medrol Dosepack last night, 11May2021. Caller reported that she just took a couple because she was afraid to take all 6 tablets at once.  It has been 2 weeks since her 2nd vaccine. She has not had a flare up like this for 6 months. The events outcome was unknown.    Description of complaint: Caller reported that she doesn't know if the Pfizer Covid-19 vaccine works.  Caller reported that the Pfizer Covid-19 vaccine works for some people and it depends if you build up immunity.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: "feels like I am having an autoimmune flare up, I feel so fatigued and crappy; "feels like I am having an autoimmune flare up, I feel so fatigued and crappy; "feels like I am having an autoimmune flare up, I feel so fatigued and crappy; "feels like I am having an autoimmune flare up, I feel so fatigued and crappy; cannot lift her head up; scared; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Apr2021 as single dose for covid-19 immunisation. First dose was administered on 06Apr2021. Medical history included rheumatoid arthritis, ongoing Sjogren's, ongoing epilepsy, ongoing autoimmune disorder. The patient's concomitant medications were not reported. The patient experienced "feels like i am having an autoimmune flare up, i feel so fatigued and crappy'' on May2021, cannot lift her head up on May2021, scared on May2021. Her doctor prescribed a medrol dose pack to take orally, 4mg po. "I was suppose to take 6 of the pills last night and I only took 2 pills." Caller reported that sometimes the steroids helps with the fatigue from her autoimmune disorder and that is how her physician treats it. Caller reported that she started taking the Medrol Dosepack last night, 11May2021. Caller reported that she just took a couple because she was afraid to take all 6 tablets at once.  It has been 2 weeks since her 2nd vaccine. She has not had a flare up like this for 6 months. The events outcome was unknown.    Description of complaint: Caller reported that she doesn't know if the Pfizer Covid-19 vaccine works.  Caller reported that the Pfizer Covid-19 vaccine works for some people and it depends if you build up immunity.  Information on the lot/batch number has been requested
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Joint swelling, Migraine, Mouth ulceration
Clinical narrative: body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Apr2021 09:00, at 61 years of age, (Batch/Lot number ER8737) as single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and ongoing (she has had it for years), hypertension started about 8 years before this report and ongoing, immunodeficiency from an unknown date and ongoing, her spleen has been removed and she is immune compromised and has had COVID. The patient reported that after the first dose of Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 30Mar2021 at 09:00, she had mild diarrhea, body aches, fever and headaches and she felt she had COVID. The patient's concomitant medications were not reported. In Apr2021 the patient experienced body swelling, assessed as medically significant, swollen joints, ulcers breaking out inside her mouth and a 24 hour migraine headache. Ulcers started about 3 days in from the 2nd dose, they come and go. She keeps them at bay by using Listerine. She understands that whatever is happening in her lower gastrointestinal tract is coming up into her mouth. The patient added she is a neuro-muscular therapist and had an understanding of how her body works. The body swollen started a week after the shot (also reported as immediately after the shot). It continues at the time of the report and it is persisting. The patient stated "she has a little bit of COVID brain". Moreover, the mild diarrhea after the first dose changed to constant diarrhea after the second dose. It is water and with intense cramping and is constant. She reported she is on the BRAT diet. "It won't hold so she is living on Gatorade and white rice". Over the past week, her joints in her hands and in her body have become swollen. Horribly swollen to the point she couldn't get her pants on because her knees and ankles were so swollen. Her hands last week started swelling and the pores around her joints look like blisters. The patient added she has had severe brain fog since an unknown date which was ongoing at the time of the report. The headache has not left as well, the outcome of all the events was unknown at the time of the report. The patient has not been to the Emergency Department or her Physicians office, but was going at the day of the report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Apr2021 09:00, at 61 years of age, (Batch/Lot number ER8737) as single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and ongoing (she has had it for years), hypertension started about 8 years before this report and ongoing, immunodeficiency from an unknown date and ongoing, her spleen has been removed and she is immune compromised and has had COVID. The patient reported that after the first dose of Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 30Mar2021 at 09:00, she had mild diarrhea, body aches, fever and headaches and she felt she had COVID. The patient's concomitant medications were not reported. In Apr2021 the patient experienced body swelling, assessed as medically significant, swollen joints, ulcers breaking out inside her mouth and a 24 hour migraine headache. Ulcers started about 3 days in from the 2nd dose, they come and go. She keeps them at bay by using Listerine. She understands that whatever is happening in her lower gastrointestinal tract is coming up into her mouth. The patient added she is a neuro-muscular therapist and had an understanding of how her body works. The body swollen started a week after the shot (also reported as immediately after the shot). It continues at the time of the report and it is persisting. The patient stated "she has a little bit of COVID brain". Moreover, the mild diarrhea after the first dose changed to constant diarrhea after the second dose. It is water and with intense cramping and is constant. She reported she is on the BRAT diet. "It won't hold so she is living on Gatorade and white rice". Over the past week, her joints in her hands and in her body have become swollen. Horribly swollen to the point she couldn't get her pants on because her knees and ankles were so swollen. Her hands last week started swelling and the pores around her joints look like blisters. The patient added she has had severe brain fog since an unknown date which was ongoing at the time of the report. The headache has not left as well, the outcome of all the events was unknown at the time of the report. The patient has not been to the Emergency Department or her Physicians office, but was going at the day of the report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: about to faint; dizzy/light headed; numbness and pain in left arm; numbness and pain in left arm; on Friday ECG was abnormal, but on Sunday ECG was normal; chest pain became intermittently severe; develop slow and gradual trouble breathing/still having trouble breathing; This is a spontaneous report from a contactable consumer (patient's husband).  A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #ER8735, Exp date 31Jul2021) intramuscularly in arm right on 30Apr2021 09:45 (at the age of 38-year-old) at single dose for COVID-19 immunisation. Relevant medical history included wheezing (during school age she had trouble breathing/wheezing but has not had trouble since then). Family medical history relevant to the event includes that her father is diabetic and heart patient. Concomitant medications were not reported. The patient had not prior vaccination within 4 weeks. After receiving the first dose of COVID vaccine the patient began experiencing slow and gradual trouble breathing on 01May2021 and chest pain on 02May2021. Breathing difficulties worsened and chest pain became intermittently severe, it was on and off. The patient presented to ER on 07May2021 and 09May2021. She had no previous history of chest pain or breathing difficulties. Five days after the shot in the evening she felt dizzy and lightheaded and about to faint. Until then trouble breathing had been mild, that is when she went to the ER. Chest pain was severe on the day she went to the ER, prior to that it was mild. She also developed numbness and pain in left arm. The first day she went to ER (07May2021) they did blood work, ECG, and x-ray. After 3 to 4 hours she became a little normal and they came back home. It was busy in the ER and they were not able to meet the doctor on that day. She had to go back to emergency room on 09May2021 because of the same symptoms and the same trouble breathing. All tests were repeated and then they were able to meet the doctor on 09May2021. On 07May2021 ECG was abnormal, but on 09May2021 it was normal. When she had the dizziness and severe symptoms by the time she was waiting and relaxing her vital went back normal. Nothing was found in the test they did so far. Chest pain and issues with breathing had not resolved, while outcome of the other events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Hypoaesthesia, Pain in extremity, SARS-CoV-2 test, Syncope
Clinical narrative: about to faint; dizzy/light headed; numbness and pain in left arm; numbness and pain in left arm; on Friday ECG was abnormal, but on Sunday ECG was normal; chest pain became intermittently severe; develop slow and gradual trouble breathing/still having trouble breathing; This is a spontaneous report from a contactable consumer (patient's husband).  A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #ER8735, Exp date 31Jul2021) intramuscularly in arm right on 30Apr2021 09:45 (at the age of 38-year-old) at single dose for COVID-19 immunisation. Relevant medical history included wheezing (during school age she had trouble breathing/wheezing but has not had trouble since then). Family medical history relevant to the event includes that her father is diabetic and heart patient. Concomitant medications were not reported. The patient had not prior vaccination within 4 weeks. After receiving the first dose of COVID vaccine the patient began experiencing slow and gradual trouble breathing on 01May2021 and chest pain on 02May2021. Breathing difficulties worsened and chest pain became intermittently severe, it was on and off. The patient presented to ER on 07May2021 and 09May2021. She had no previous history of chest pain or breathing difficulties. Five days after the shot in the evening she felt dizzy and lightheaded and about to faint. Until then trouble breathing had been mild, that is when she went to the ER. Chest pain was severe on the day she went to the ER, prior to that it was mild. She also developed numbness and pain in left arm. The first day she went to ER (07May2021) they did blood work, ECG, and x-ray. After 3 to 4 hours she became a little normal and they came back home. It was busy in the ER and they were not able to meet the doctor on that day. She had to go back to emergency room on 09May2021 because of the same symptoms and the same trouble breathing. All tests were repeated and then they were able to meet the doctor on 09May2021. On 07May2021 ECG was abnormal, but on 09May2021 it was normal. When she had the dizziness and severe symptoms by the time she was waiting and relaxing her vital went back normal. Nothing was found in the test they did so far. Chest pain and issues with breathing had not resolved, while outcome of the other events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement, X-ray
Clinical narrative: about to faint; dizzy/light headed; numbness and pain in left arm; numbness and pain in left arm; on Friday ECG was abnormal, but on Sunday ECG was normal; chest pain became intermittently severe; develop slow and gradual trouble breathing/still having trouble breathing; This is a spontaneous report from a contactable consumer (patient's husband).  A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #ER8735, Exp date 31Jul2021) intramuscularly in arm right on 30Apr2021 09:45 (at the age of 38-year-old) at single dose for COVID-19 immunisation. Relevant medical history included wheezing (during school age she had trouble breathing/wheezing but has not had trouble since then). Family medical history relevant to the event includes that her father is diabetic and heart patient. Concomitant medications were not reported. The patient had not prior vaccination within 4 weeks. After receiving the first dose of COVID vaccine the patient began experiencing slow and gradual trouble breathing on 01May2021 and chest pain on 02May2021. Breathing difficulties worsened and chest pain became intermittently severe, it was on and off. The patient presented to ER on 07May2021 and 09May2021. She had no previous history of chest pain or breathing difficulties. Five days after the shot in the evening she felt dizzy and lightheaded and about to faint. Until then trouble breathing had been mild, that is when she went to the ER. Chest pain was severe on the day she went to the ER, prior to that it was mild. She also developed numbness and pain in left arm. The first day she went to ER (07May2021) they did blood work, ECG, and x-ray. After 3 to 4 hours she became a little normal and they came back home. It was busy in the ER and they were not able to meet the doctor on that day. She had to go back to emergency room on 09May2021 because of the same symptoms and the same trouble breathing. All tests were repeated and then they were able to meet the doctor on 09May2021. On 07May2021 ECG was abnormal, but on 09May2021 it was normal. When she had the dizziness and severe symptoms by the time she was waiting and relaxing her vital went back normal. Nothing was found in the test they did so far. Chest pain and issues with breathing had not resolved, while outcome of the other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis, Blood test, Computerised tomogram
Clinical narrative: severe abdominal cramping and ongoing pain; appendicitis; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for SARS-COV-2 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 for COVID-19 immunization. On 12Apr2021 15:00, the patient experienced severe abdominal cramping and ongoing pain that would not subside. She went to the Emergency Room where they did a CT scan and blood work which confirmed she had appendicitis. Since then, she had eaten and wasn't at immediate risk for appendix rupture; her surgery was done on 12Apr2021 in the evening. There were no complications and she stated later in the call that she was ambulatory and home by 2100 on 12Apr2021. She was never admitted into the hospital. Since the surgery, she has met with the surgeon. The surgeon said that upon examination, the surgeon did not think the caller had any sort of ongoing appendicitis before this event. Vaccination facility type was clinic. The outcome of the event 'appendicitis' was recovered on 12Apr2021 and the outcome of the event 'severe abdominal cramping and ongoing pain' was unknown.  Information on lot/batch number was not available. Additional information has been requested.