chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, SARS-CoV-2 test
Clinical narrative: flare up of irritable bowel symptoms; flare up of irritable bowel symptoms; This is a spontaneous report from a non-contactable consumer (the patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via unspecified route of administration on 02Mar2021 (at the age of 64-years-old) as a single dose for Covid-19 immunisation. The patient's medical history included quadriplegia from an unspecified date, irritable bowel syndrome from an unspecified date. Allergies to medications, food, or other products included patient had known allergies to Sulfa drugs. Concomitant medications included unspecified multiple medications. List of any other medications the patient received within 2 weeks of vaccination reported as Yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 11Mar2021, the patient experienced flare up of irritable bowel symptoms. Adverse event resulted in emergency room visit. The patient received treatment for the reported event. The patient underwent lab tests and procedures which included Nasal Swab (sars-cov-2 test): negative on an unspecified date. The outcome of the flare up of irritable bowel symptoms were recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter's name added in general tab. Protect Confidentiality checked since reporter is the patient self. Patient's first name updated. Patient's Country was added as United States. BNT162B2 Stop date/time added. Dose description was updated as "1ST DOSE, SINGLE DOSE". Lot# UNKNOWN was removed from dosage regimens tab. Concomitant therapy updated as Yes since "take multiple meds" was provided. Emergency Room Visit checked. Treatment received was ticked as Yes. "known allergies: sulfa drugs" was added as relevant med history. County of Primary reporter should be leave blank not US.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash the following day after vaccine on both legs and arms; Itchy rash the following day after vaccine on both legs and arms; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0169) via an unspecified route of administration on 07May2021 at 10:00 (at the age of 55-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not have any known allergies. Concomitant medications included doxycycline from an unknown date for an unknown indication. On 08May2021 at 08:00 the patient experienced an itchy rash the following day after vaccine on both legs and arms. The patient did not receive any treatment for the event. The outcome of itchy rash was not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: head cold; nose congestion; This is a spontaneous report from a contactable consumer (patient) and Pfizer sponsored programmer. A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Apr2021 at single dose for COVID-19 immunisation at the age of 47-year-old. Medical history and concomitant medications were unknown. The patient experienced head cold in the last two days. The patient had nose congestion. The patient had no fever, aches, no loss of smell or taste, and nothing in her throat. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; The initial case was missing the following minimum criteria: identifiable Event. Upon receipt of follow-up information on 4Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 87-years-old female patient (Age at Time of Vaccination in 87Years) received bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0175, Expiration date: unknown)), dose 1 via an unspecified route of administration, administered in Arm Left as 1st dose, single dose for covid-19 immunisation in a church. Medical history included ongoing hypertension (diagnosed with high blood pressure 10 years ago or something like that), ongoing anxiety (diagnosed with anxiety about 2 years ago as she had to be in isolation for 2 weeks and that her problem with anxiety began afterwards), ongoing atrial fibrillation, hip surgery few years ago. Adverse event following prior vaccinations includes sort of bothered her face after Flu shot reported that the event occurred 40-50 years ago and she never got another flu shot. No prior vaccinations within 4 weeks. Concomitant medication included warfarin (WARFARIN) taken for atrial fibrillation (3 mg of Warfarin daily Tuesday, Thursday, Saturday, Sunday, and 1.5 mg daily on Monday, Wednesday, Friday, she has been taking Warfarin for at least 6 years), olmesartan medoxomil (BENICAR) taken for blood pressure abnormal (taking for about 3 years); nebivolol hydrochloride (BYSTOLIC) taken for blood pressure abnormal (taking for about 3 years); diltiazem hydrochloride (DILTIAZEM CD) taken for blood pressure abnormal (taking for about 3 years); clonazepam (CLONAZEPAM) taking for about 2 years. The patient began feeling tired about 4-5 days (In May2021) after she received her first dose of the Covid-19 vaccine. No Emergency Room or Physician Office visit required. Tiredness lasted for 3-4 days and then she was fine. Did not performed any relevant Tests. Caller declined to provide her email address, her physicians information. The outcome of the event was recovered.
Sex: U
Vaccine: COVID19
Symptoms: Foetal death, Foetal exposure during pregnancy, Foetal growth restriction
Clinical narrative: I ended up with a miscarriage; fetus I was pregnant with stopped growing at 5.5 weeks; I was pregnant with stopped growing at 5.5 weeks which happens to be the same time I had the vaccine.; This is a spontaneous report from a contactable consumer. This consumer (mother) reported similar events for self and the foetus. This report for foetus included that:  A fetus received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, via transplacental route, on 17Mar2021 13:30 as 1 st dose, single dose for covid-19 immunization. Also received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, via transplacental route, on 07Apr2021 13:30 as 2 nd dose, single dose for covid-19 immunization. The patient medical history was not reported. The concomitant drugs included Prenatal Vitamin, Iron Supplement, Zoloft which patient had received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was the workplace clinic. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 and had no allergies. The patient reported that on 07Apr2021 the foetus she was pregnant with stopped growing at 5.5 weeks which happened to be the same time she had the vaccine. She ended up with a miscarriage which resulted in doctor or other healthcare professional office/clinic visit. The patient had received the treatment. The outcome of the event was fatal.  Follow-up attempts are needed. Further information is expected  Follow-up (07Jun2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021536223 fetal case and maternal case; Reported Cause(s) of Death: Fetal death
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea exertional, Fatigue, Gait disturbance
Clinical narrative: sleeping over 12 hours a day; Nausea; Vertigo; Dizziness; Diarrhea; Ringing in ears; severe itching; vision change; change with taste; change with smell; excessive thirst; unable to drive; Vision seeing flashes of light; vision seeing dark floaters; Difficulty walking; exhaustion; winded from taking a few steps; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on Mar2021 (at 52-year-old, not pregnant at the time of vaccination) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included other medications in two weeks. No other medications in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534), via an unspecified route of administration, administered in left arm on Mar2021 at 05:00 PM (at 52-year-old) as single dose for COVID-19 immunization. On 11Apr2021 at 12:00 PM, the patient experienced nausea, vertigo, dizziness, diarrhea, ringing in ears, severe itching, winded from taking a few steps, vision change, change with smell, change with taste, excessive thirst, unable to drive, vision seeing flashes of light, vision seeing dark floaters, difficulty walking, exhaustion, sleeping over 12 hours a day. The events resulted doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment for the events was unknown. The patient underwent lab tests and procedures which included Nasal Swab post vaccination: negative on 08May2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Impaired driving ability, Nausea, Parosmia, Photopsia
Clinical narrative: sleeping over 12 hours a day; Nausea; Vertigo; Dizziness; Diarrhea; Ringing in ears; severe itching; vision change; change with taste; change with smell; excessive thirst; unable to drive; Vision seeing flashes of light; vision seeing dark floaters; Difficulty walking; exhaustion; winded from taking a few steps; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on Mar2021 (at 52-year-old, not pregnant at the time of vaccination) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included other medications in two weeks. No other medications in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534), via an unspecified route of administration, administered in left arm on Mar2021 at 05:00 PM (at 52-year-old) as single dose for COVID-19 immunization. On 11Apr2021 at 12:00 PM, the patient experienced nausea, vertigo, dizziness, diarrhea, ringing in ears, severe itching, winded from taking a few steps, vision change, change with smell, change with taste, excessive thirst, unable to drive, vision seeing flashes of light, vision seeing dark floaters, difficulty walking, exhaustion, sleeping over 12 hours a day. The events resulted doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment for the events was unknown. The patient underwent lab tests and procedures which included Nasal Swab post vaccination: negative on 08May2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Taste disorder, Thirst, Tinnitus
Clinical narrative: sleeping over 12 hours a day; Nausea; Vertigo; Dizziness; Diarrhea; Ringing in ears; severe itching; vision change; change with taste; change with smell; excessive thirst; unable to drive; Vision seeing flashes of light; vision seeing dark floaters; Difficulty walking; exhaustion; winded from taking a few steps; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on Mar2021 (at 52-year-old, not pregnant at the time of vaccination) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included other medications in two weeks. No other medications in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534), via an unspecified route of administration, administered in left arm on Mar2021 at 05:00 PM (at 52-year-old) as single dose for COVID-19 immunization. On 11Apr2021 at 12:00 PM, the patient experienced nausea, vertigo, dizziness, diarrhea, ringing in ears, severe itching, winded from taking a few steps, vision change, change with smell, change with taste, excessive thirst, unable to drive, vision seeing flashes of light, vision seeing dark floaters, difficulty walking, exhaustion, sleeping over 12 hours a day. The events resulted doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment for the events was unknown. The patient underwent lab tests and procedures which included Nasal Swab post vaccination: negative on 08May2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Visual impairment, Vitreous floaters
Clinical narrative: sleeping over 12 hours a day; Nausea; Vertigo; Dizziness; Diarrhea; Ringing in ears; severe itching; vision change; change with taste; change with smell; excessive thirst; unable to drive; Vision seeing flashes of light; vision seeing dark floaters; Difficulty walking; exhaustion; winded from taking a few steps; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on Mar2021 (at 52-year-old, not pregnant at the time of vaccination) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included other medications in two weeks. No other medications in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534), via an unspecified route of administration, administered in left arm on Mar2021 at 05:00 PM (at 52-year-old) as single dose for COVID-19 immunization. On 11Apr2021 at 12:00 PM, the patient experienced nausea, vertigo, dizziness, diarrhea, ringing in ears, severe itching, winded from taking a few steps, vision change, change with smell, change with taste, excessive thirst, unable to drive, vision seeing flashes of light, vision seeing dark floaters, difficulty walking, exhaustion, sleeping over 12 hours a day. The events resulted doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment for the events was unknown. The patient underwent lab tests and procedures which included Nasal Swab post vaccination: negative on 08May2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration, Syncope, Thirst
Clinical narrative: Fainted twice (once a few min after and the second about 12 hours later); dizziness for a few weeks; headaches; had been drinking a lot of water; patient received both the first dose and the second dose of BNT162B2 on 29Apr2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 29Apr2021 (batch/lot number was not reported) at 44 years old as 1ST DOSE, SINGLE and via an unspecified route of administration, administered in the left arm on 29Apr2021 (batch/lot number was not reported) at 44 years old as 2ND DOSE, SINGLE for COVID-19 immunization. The patient received the vaccination in Other Facility. The patient had no medical history. The patient was not pregnant. Concomitant medication received within 2 weeks of vaccination included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient received both the first dose and the second dose of BNT162B2 on 29Apr2021 (pending confirmation). On 29Apr2021, the patient fainted twice (once a few min after and the second about 12 hours later). The patient also experienced dizziness for a few weeks and headaches since 29Apr2021. After the second injection on 29Apr2021, patient had been drinking a lot of water but eight (8) days after the injection, patient still experienced significant dizziness. No treatment was received in response to the events faint, dizziness, headache, and increased thirst. The outcome of the events faint, dizziness, headache, and increased thirst at the time of last observation was not recovered/not resolved.   Information about the batch/lot numbers has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: pemphigus; This spontaneous report from a contactable pharmacist reporting same event under the same suspect product for 6 patients. This is one of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. It was reported that while consulting her (reporter) dermatologist, she was informed that there are 6 patients who had pemphigus after receiving COVID vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021615652 Same reporter/drug/event, different patient;US-PFIZER INC-2021685995 Same reporter/drug/event, different patient;US-PFIZER INC-2021685959 Same reporter/drug/event, different patient;US-PFIZER INC-2021685997 Same reporter/drug/event, different patient;US-PFIZER INC-2021685996 Same reporter/drug/event, different patient
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Pneumonia
Clinical narrative: Loss of smell; Lung infection; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on 09Apr2021 (09:00) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN620F; Expiration date was not reported) on 19Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 24May2021, the patient had lung infection. The patient went to the doctor (physician's office visit), and was put on antibiotic (doxycycline 100 mg, by mouth twice daily) and hydrocodone every six hours as treatment for the lung infection. On 28May2021, the patient had loss of smell (could smell some things but not others). The outcome of the events was not recovered for loss of smell; and was unknown for lung infection.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Electrocardiogram, Eye haemorrhage, Eye pruritus
Clinical narrative: sore arm; she experienced a sore arm, fever, chills, wasn't feeling well; she experienced a sore arm, fever, chills, wasn't feeling well; she experienced a sore arm, fever, chills, wasn't feeling well; fatigue that has continued, and itching in her eyes; fatigue that has continued, and itching in her eyes; she had a panic attack; On 22 May a blood vessel burst in her left eye; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: CW0179 or EW0179), via an unspecified route of administration, administered in left arm on 09May2021 13:00 at the age of 63 years as single dose for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (Lot number: ER8731) via an unspecified route of administration, administered in left arm on 18Apr2021 13:00 as single dose for covid-19 immunisation and experienced left toe swelling and she could hardly walk and fatigue. After dose two she experienced a sore arm, fever, chills, wasn't feeling well for about 2 days, fatigue that has continued, and itching in her eyes. The eye doctor said it was possible the eye itching was related but they were not sure. On 22May a blood vessel burst in her left eye and she was given antibiotic eye drops to use. On 24May she had a panic attack. She had her second Covid 19 vaccine on 09May2021 and she experienced a sore arm, fever, chills and she wasn't feeling well for about two days. The fatigue continued. She then experienced itching in her eyes like eye issues. She went to her eye doctor and the doctor told her her eye issues were possibly related to the Covid 19 vaccine but they weren't sure. Then this past Saturday, 22May2021 she had a blood vessel burst in her left eye. She was not sure if that was related to the Covid 19 vaccine but all these things were happening to her. She received her second Covid 19 vaccine on 09May2021 in the left arm. She reported she was on the fence about getting the Covid 19 vaccine but her daughter and her husband encour-aged her to get it. At her doctor's office she also had an EKG and a urinalysis done and everything came back ok. She ended up going to her doctor's office again because she was having a panic at-tack. She hadn't been feeling well and she thought it was affecting her mentally. She received an anti-biotic eye drop for her burst blood vessel. Ofloxacin 0.3% 1 drop in the left eye 3 times daily for 7 days. The antibiotic she received from the urgent care for her toe was Amoxicillin-Clavulanate 875-125mg, take one tablet every 12 hours for 5days. Itchy eyes, burst blood vessel in left eye, panic attack required a visit to physician office. Relevant Tests included bloodwork, urinalysis, EKG. Outcome of events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Panic attack, Pyrexia
Clinical narrative: sore arm; she experienced a sore arm, fever, chills, wasn't feeling well; she experienced a sore arm, fever, chills, wasn't feeling well; she experienced a sore arm, fever, chills, wasn't feeling well; fatigue that has continued, and itching in her eyes; fatigue that has continued, and itching in her eyes; she had a panic attack; On 22 May a blood vessel burst in her left eye; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: CW0179 or EW0179), via an unspecified route of administration, administered in left arm on 09May2021 13:00 at the age of 63 years as single dose for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (Lot number: ER8731) via an unspecified route of administration, administered in left arm on 18Apr2021 13:00 as single dose for covid-19 immunisation and experienced left toe swelling and she could hardly walk and fatigue. After dose two she experienced a sore arm, fever, chills, wasn't feeling well for about 2 days, fatigue that has continued, and itching in her eyes. The eye doctor said it was possible the eye itching was related but they were not sure. On 22May a blood vessel burst in her left eye and she was given antibiotic eye drops to use. On 24May she had a panic attack. She had her second Covid 19 vaccine on 09May2021 and she experienced a sore arm, fever, chills and she wasn't feeling well for about two days. The fatigue continued. She then experienced itching in her eyes like eye issues. She went to her eye doctor and the doctor told her her eye issues were possibly related to the Covid 19 vaccine but they weren't sure. Then this past Saturday, 22May2021 she had a blood vessel burst in her left eye. She was not sure if that was related to the Covid 19 vaccine but all these things were happening to her. She received her second Covid 19 vaccine on 09May2021 in the left arm. She reported she was on the fence about getting the Covid 19 vaccine but her daughter and her husband encour-aged her to get it. At her doctor's office she also had an EKG and a urinalysis done and everything came back ok. She ended up going to her doctor's office again because she was having a panic at-tack. She hadn't been feeling well and she thought it was affecting her mentally. She received an anti-biotic eye drop for her burst blood vessel. Ofloxacin 0.3% 1 drop in the left eye 3 times daily for 7 days. The antibiotic she received from the urgent care for her toe was Amoxicillin-Clavulanate 875-125mg, take one tablet every 12 hours for 5days. Itchy eyes, burst blood vessel in left eye, panic attack required a visit to physician office. Relevant Tests included bloodwork, urinalysis, EKG. Outcome of events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: sore arm; she experienced a sore arm, fever, chills, wasn't feeling well; she experienced a sore arm, fever, chills, wasn't feeling well; she experienced a sore arm, fever, chills, wasn't feeling well; fatigue that has continued, and itching in her eyes; fatigue that has continued, and itching in her eyes; she had a panic attack; On 22 May a blood vessel burst in her left eye; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: CW0179 or EW0179), via an unspecified route of administration, administered in left arm on 09May2021 13:00 at the age of 63 years as single dose for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (Lot number: ER8731) via an unspecified route of administration, administered in left arm on 18Apr2021 13:00 as single dose for covid-19 immunisation and experienced left toe swelling and she could hardly walk and fatigue. After dose two she experienced a sore arm, fever, chills, wasn't feeling well for about 2 days, fatigue that has continued, and itching in her eyes. The eye doctor said it was possible the eye itching was related but they were not sure. On 22May a blood vessel burst in her left eye and she was given antibiotic eye drops to use. On 24May she had a panic attack. She had her second Covid 19 vaccine on 09May2021 and she experienced a sore arm, fever, chills and she wasn't feeling well for about two days. The fatigue continued. She then experienced itching in her eyes like eye issues. She went to her eye doctor and the doctor told her her eye issues were possibly related to the Covid 19 vaccine but they weren't sure. Then this past Saturday, 22May2021 she had a blood vessel burst in her left eye. She was not sure if that was related to the Covid 19 vaccine but all these things were happening to her. She received her second Covid 19 vaccine on 09May2021 in the left arm. She reported she was on the fence about getting the Covid 19 vaccine but her daughter and her husband encour-aged her to get it. At her doctor's office she also had an EKG and a urinalysis done and everything came back ok. She ended up going to her doctor's office again because she was having a panic at-tack. She hadn't been feeling well and she thought it was affecting her mentally. She received an anti-biotic eye drop for her burst blood vessel. Ofloxacin 0.3% 1 drop in the left eye 3 times daily for 7 days. The antibiotic she received from the urgent care for her toe was Amoxicillin-Clavulanate 875-125mg, take one tablet every 12 hours for 5days. Itchy eyes, burst blood vessel in left eye, panic attack required a visit to physician office. Relevant Tests included bloodwork, urinalysis, EKG. Outcome of events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test, Sepsis
Clinical narrative: Severe Pneumonia; Sepsis; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:00 (Batch/Lot Number: EW0750) as 1st dose, single for covid-19 immunisation. Medical history included asthma and GERD (gastrooesophageal reflux disease). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and sulfa [sulfanilamide] both which patient experienced allergies. On 28Apr2021, the patient experienced severe pneumonia and sepsis with symptom of fever which began around 29Apr2021. The events required hospitalization from 05May2021 to 09May2021. The patient was treated with IV and oral antibiotics, oxygen and breathing Tmt. The patient underwent lab tests and procedures which included nasal swab on 26Apr2021 which result was negative. The outcome of the events was recovering.  Follow up needed, further information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Received first dose of vaccine on May 6th and had a miscarriage on May 18th.; This is a spontaneous report received from a contactable consumer (patient).   A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06May2021 15:45 (Lot Number: ER 8735) as single dose (at the age of 33-years-old) for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified prenatal vitamins. The patient received first dose of vaccine on 06May2021 and had a miscarriage on 18May2021 00:00 (reported as 12:00 AM). The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 12Jan2022. Patient's last menstrual period date was on 07Apr2021. The pregnancy resulted in spontaneous abortion. No treatment received for the event. The outcome of the event was recovering. The event was considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was in 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.  Device Date: 28May2021  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Fatigue, Laboratory test, SARS-CoV-2 test
Clinical narrative: Began experiencing irregular heartbeat; severe fatigue; This is a spontaneous report from a contactable consumer. A 56-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 19Mar2021 (Lot Number: EN6204) as 2nd dose, single dose for covid-19 immunisation. Medical history included penicillin allergy. The patient was not diagnosed with covid-19 prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) dose 1 at vaccination age of 56-year-old via an unspecified route of administration in the left arm on 26Feb2021 (Lot Number: E6202) as 1st dose, single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient received the vaccine in a hospital. The patient did not receive other vaccine in four weeks. On 01May2021, the patient began experiencing irregular heartbeat as well as experienced severe fatigue for about 4 weeks after second vaccine. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events required treatment which included heart monitor and echocardiogram with medication. The patient underwent lab tests and procedures which included sars-cov-2 nasal swab was negative on Mar2021. The outcome of the events was not recovered.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomyopathy, Chills, Dyspnoea, Ejection fraction, Fatigue
Clinical narrative: significant fatigue; peculiarly sticky but productive afebrile cough; shortness of breath; hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%; Afebrile chills; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 17Apr2021 11:00 (at the age of 45-year-old) (Batch/Lot Number: EW0162) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient has not been diagnosed with covid-19 prior to vaccination and has been tested for covid-19 via nasal swab on 21May2021 which showed negative. Medical history included hypertension, depression, anxiety, attention deficit hyperactivity disorder (ADHD), and known allergies to Bactrim and Modanifil. Concomitant medications included methylphenidate hydrochloride (CONCERTA); vortioxetine hydrobromide (TRINTELLIX); bupropion; losartan; and zolpidem. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER2613) in the left arm on 23Mar2021 (at the age of 45-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. On 18Apr2021, the patient experienced afebrile chills which was resolved after about 18 hours bedrest. Furthermore, four days post-vaccination (20Apr2021), it was reported that suddenly back in bed, this time with significant fatigue and a peculiarly sticky but productive afebrile cough that responded to neither dextromethorphan nor guaifenesin, nor to liberal and frequent coadministration of these two drugs. Partial resolution by Friday, 22Apr2021. No chills that he remembers. Much more debilitating than the initial reaction (afebrile chills) described earlier. Cough has come and gone for weeks, never resolving for more than about three days at a stretch. About three weeks ago, patient began to suffer shortness of breath for the first time in his life - while making a very easy (and routine) walk from his car into CVS and back. The patient has been hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%. The onset date of shortness of breath and cardiomyopathy was 18Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which includes Lasix, milrinone, metoprolol, and carvedilol. On an unspecified date in Apr2021, the patient recovered from afebrile chills while outcome of the rest of the events was not yet recovered.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, SARS-CoV-2 test
Clinical narrative: significant fatigue; peculiarly sticky but productive afebrile cough; shortness of breath; hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%; Afebrile chills; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 17Apr2021 11:00 (at the age of 45-year-old) (Batch/Lot Number: EW0162) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient has not been diagnosed with covid-19 prior to vaccination and has been tested for covid-19 via nasal swab on 21May2021 which showed negative. Medical history included hypertension, depression, anxiety, attention deficit hyperactivity disorder (ADHD), and known allergies to Bactrim and Modanifil. Concomitant medications included methylphenidate hydrochloride (CONCERTA); vortioxetine hydrobromide (TRINTELLIX); bupropion; losartan; and zolpidem. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER2613) in the left arm on 23Mar2021 (at the age of 45-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. On 18Apr2021, the patient experienced afebrile chills which was resolved after about 18 hours bedrest. Furthermore, four days post-vaccination (20Apr2021), it was reported that suddenly back in bed, this time with significant fatigue and a peculiarly sticky but productive afebrile cough that responded to neither dextromethorphan nor guaifenesin, nor to liberal and frequent coadministration of these two drugs. Partial resolution by Friday, 22Apr2021. No chills that he remembers. Much more debilitating than the initial reaction (afebrile chills) described earlier. Cough has come and gone for weeks, never resolving for more than about three days at a stretch. About three weeks ago, patient began to suffer shortness of breath for the first time in his life - while making a very easy (and routine) walk from his car into CVS and back. The patient has been hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%. The onset date of shortness of breath and cardiomyopathy was 18Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which includes Lasix, milrinone, metoprolol, and carvedilol. On an unspecified date in Apr2021, the patient recovered from afebrile chills while outcome of the rest of the events was not yet recovered.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Tongue injury
Clinical narrative: Seizure; I had bitten my tongue; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0191) via an unspecified route of administration, administered on the left arm on 27May2021 14:45 as 2nd dose, single for COVID-19 immunisation. Medical history included Type 1 diabetes, epilepsy and PCOS. Concomitant medications included insulin aspart (NOVOLOG); insulin glargine (LANTUS); levetiracetam (KEPPRA); drospirenone, ethinylestradiol (OCELLA) and cran-stat. The patient previously received first dose of BNT162B2 on 06May2021 for COVID-19 immunization (lot number: EW0173, on 06May2021 01:30 PM, left arm). On 28May2021 11:30 AM, the day after 2nd shot the patient woke up on the kitchen floor. She believed she had a seizure because she couldn't remember falling and she had bitten her tongue. No treatment was received for the events. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Computerised tomogram, Lymphadenopathy, Magnetic resonance imaging, Muscle tightness
Clinical narrative: Secondary cellulitis; Onset tightness left forearm with swelling; Onset tightness left forearm with swelling/Left arm circumference 2.5 inch more than right; Shotty lymph nodes; mild left supraclavicular swelling/Axillary swelling/soft tissues swelling; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), intramuscular, administered in the left arm on 29Mar2021 as a single dose for COVID-19 immunization. Medical history included allergies to latex and pineapple, seasonal allergies, thrombocytopenia and chronic prostatitis (reported as chr prostatitis) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amitriptyline hydrochloride (ELAVIL); marijuana and meloxicam (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 on 08Mar2021 (lot number and expiry date unknown), intramuscular on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 19May2021, the patient experienced the onset of tightness left forearm with swelling. The left arm circumference was 2.5 inch more than right with mild left supraclavicular swelling. The patient went to the ER and had an ultrasound of left upper extremity including subclavian and cephalic veins which showed no DVT, MRA showed no arterial clots, CT with contrast showed axillary swelling, shotty lymph nodes, soft tissues swelling, no tumor nor clots. The patient was administered with cefadroxil as he may have secondary cellulitis. The patient had not recovered from the events.   Information on the lot/batch number has been requested.; Sender's Comments: The causal association between the event secondary cellulitis ad the suspect drug BNT162B2 cannot be totally excluded based on a temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling, Ultrasound scan
Clinical narrative: Secondary cellulitis; Onset tightness left forearm with swelling; Onset tightness left forearm with swelling/Left arm circumference 2.5 inch more than right; Shotty lymph nodes; mild left supraclavicular swelling/Axillary swelling/soft tissues swelling; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), intramuscular, administered in the left arm on 29Mar2021 as a single dose for COVID-19 immunization. Medical history included allergies to latex and pineapple, seasonal allergies, thrombocytopenia and chronic prostatitis (reported as chr prostatitis) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amitriptyline hydrochloride (ELAVIL); marijuana and meloxicam (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 on 08Mar2021 (lot number and expiry date unknown), intramuscular on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 19May2021, the patient experienced the onset of tightness left forearm with swelling. The left arm circumference was 2.5 inch more than right with mild left supraclavicular swelling. The patient went to the ER and had an ultrasound of left upper extremity including subclavian and cephalic veins which showed no DVT, MRA showed no arterial clots, CT with contrast showed axillary swelling, shotty lymph nodes, soft tissues swelling, no tumor nor clots. The patient was administered with cefadroxil as he may have secondary cellulitis. The patient had not recovered from the events.   Information on the lot/batch number has been requested.; Sender's Comments: The causal association between the event secondary cellulitis ad the suspect drug BNT162B2 cannot be totally excluded based on a temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Peripheral swelling, Rash
Clinical narrative: I received a rash; I have mouth sores; I have swelling in my legs; I was tired; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (non-pregnant) received BNT162B2, first dose via an unspecified route of administration at left arm on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at age of 46-year-old (non-pregnant). The patient medical history included covid prior vaccination. Concomitant drugs were not reported. The patient had Rash, Mouth sores, swelling in her legs, was tired and headache on 10Apr2021. The events resulted to visit doctors or other Healthcare professional office/ Clinic visit, Emergency room, department or Urgent care and hospitalization for 2 days. The patient received creams as treatment for rash. The patient had Covid test on 27May2021 and Covid test result was negative. Outcome of the events was not recovered. The patient received second dose of bnt162b2 on 26Apr2021 at left arm later.   Information on the lot/batch number has been requested.