chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident
Clinical narrative: Stroke/in her head on her left side; Blockage in her head, there was a blood clot in her head; Arm doesn't work; All she could say was I cant/still needs speech therapy; Really bad headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269; Expiration date was not reported) on the left arm on 04Feb2021 (13:21) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the public health department (not a military facility). The patient had a family history of five heart bypass surgeries (father); stroke (father); and stents (mother). There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 14Jan2021 (when the patient was 68 years old) for COVID-19 immunization, and had hypersensitivity, rash and cerebrovascular accident. On 07May2021, the patient had a stroke (in her head on the left side). The patient was hospitalized from 07May2021 to 10May2021 due to the stroke. In May2021, the patient had a blockage in her head/there was a blood clot in her head; her arm did not work; all she could say was "I can't", and still needed speech therapy; and had really bad headaches. The events had resulted into an emergency room visit. The patient had received clopidogrel (PLAVIX) as treatment for stroke and blockage in her head/there was a blood clot in her head; and duloxetine ACL as treatment for the really bad headaches. The outcome of the events was recovering for 'stroke' and 'all she could say was "I can't", and still needed speech therapy'; was not recovered for 'really bad headaches'; and was unknown for all the other events.  Information on lot/batch number was available. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Headache, Musculoskeletal disorder, Speech disorder
Clinical narrative: Last week I had a stroke; This is a spontaneous report from a contactable other HCP (patient). A 67-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Patient received the first dose of bnt162b2 on 14Jan2021. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 (reported as last week), patient had a stroke. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known safety profile and available information it  is unlikely that the reported  "stroke" is causally  related to bnt162b2.  This is an intercurrent  medical  condition.  Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Last week I had a stroke; This is a spontaneous report from a contactable other HCP (patient). A 67-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Patient received the first dose of bnt162b2 on 14Jan2021. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 (reported as last week), patient had a stroke. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known safety profile and available information it  is unlikely that the reported  "stroke" is causally  related to bnt162b2.  This is an intercurrent  medical  condition.  Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Confusional state, Dysgraphia, Hypoacusis
Clinical narrative: Last week I had a stroke; This is a spontaneous report from a contactable other HCP (patient). A 67-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Patient received the first dose of bnt162b2 on 14Jan2021. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 (reported as last week), patient had a stroke. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known safety profile and available information it  is unlikely that the reported  "stroke" is causally  related to bnt162b2.  This is an intercurrent  medical  condition.  Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident
Clinical narrative: Last week I had a stroke; This is a spontaneous report from a contactable other HCP (patient). A 67-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Patient received the first dose of bnt162b2 on 14Jan2021. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 (reported as last week), patient had a stroke. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known safety profile and available information it  is unlikely that the reported  "stroke" is causally  related to bnt162b2.  This is an intercurrent  medical  condition.  Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Mild chest pain; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program,. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild chest pain (medically significant) on an unspecified date with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Trigger finger
Clinical narrative: "trigger finger" in her left middle finger; This is a spontaneous report from. A contactable nurse (patient) reported that an adult female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EM9810 (also reported as 'EL3427'), intramuscular, administered in the left arm on 15Jan2021 at 14:30 as a single dose for COVID-19 immunization.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin (manufacturer unknown) 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 underwent a nasal swab covid test on 25Jan2021 with a result of negative.  On 17Jan2021, two days after the first dose of the vaccine, the patient started to experience "trigger finger" in her left middle finger. The event resulted in a doctor/health care professional office/clinic visit. The patient received steroid injection in the left hand. The patient recovered from the event.   Information on lot and batch number has been obtained.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Abdominal pain upper, Appendicitis, Blood test, Computerised tomogram
Clinical narrative: acute appendicitis; drained from surgery; pain in the lower right quadrant of her abdomen; wasn't very hungry; thought she had a bug; stomach ache; a little diarrhea; This is a spontaneous report, received from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 70 years old as 2nd dose, single for COVID-19 immunization given in a hospital. Medical history included Demodex mites on her eyelids from an unknown date. Concomitant medication included ivermectin taken for Demodex mites on her eyelids, start and stop date were not reported. The patient received the first dose of bnt162b2 on 15Mar2021 (lot number: EN6208) 70 years old in the left arm for COVID-19 immunization. The patient also had shingles vaccine about 10 years ago in 2011 for immunization and had sore arm. On 20Apr2021, the patient had a stomach ache and a little diarrhea and though she had a little bug. On 21Apr2021, the stomach ache lasted all evening long, let up during that night. On 22Apr2021, stomach ache and diarrhea started up again and she wasn't very hungry. On 23Apr2021, she had pain in the lower right quadrant of her abdomen. She googled her symptoms and decided to go to the emergency room. On 24Apr2021, she was diagnosed with acute appendicitis and had her appendix taken out. It totally took her by surprise because she's relatively healthy. She was not admitted to the hospital. She was taken from the emergency department to surgery and was discharged around 7:00PM on Saturday, 24Apr2021. She was under observation status in the hospital. Other than feeling drained from her surgery after her appendix was removed she felt great. The patient underwent lab tests and procedures which included blood work, computerised tomogram (CT scan), and urine test all with no results on 24Apr2021. The outcome of the events was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Gastric disorder, Urine analysis
Clinical narrative: acute appendicitis; drained from surgery; pain in the lower right quadrant of her abdomen; wasn't very hungry; thought she had a bug; stomach ache; a little diarrhea; This is a spontaneous report, received from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 70 years old as 2nd dose, single for COVID-19 immunization given in a hospital. Medical history included Demodex mites on her eyelids from an unknown date. Concomitant medication included ivermectin taken for Demodex mites on her eyelids, start and stop date were not reported. The patient received the first dose of bnt162b2 on 15Mar2021 (lot number: EN6208) 70 years old in the left arm for COVID-19 immunization. The patient also had shingles vaccine about 10 years ago in 2011 for immunization and had sore arm. On 20Apr2021, the patient had a stomach ache and a little diarrhea and though she had a little bug. On 21Apr2021, the stomach ache lasted all evening long, let up during that night. On 22Apr2021, stomach ache and diarrhea started up again and she wasn't very hungry. On 23Apr2021, she had pain in the lower right quadrant of her abdomen. She googled her symptoms and decided to go to the emergency room. On 24Apr2021, she was diagnosed with acute appendicitis and had her appendix taken out. It totally took her by surprise because she's relatively healthy. She was not admitted to the hospital. She was taken from the emergency department to surgery and was discharged around 7:00PM on Saturday, 24Apr2021. She was under observation status in the hospital. Other than feeling drained from her surgery after her appendix was removed she felt great. The patient underwent lab tests and procedures which included blood work, computerised tomogram (CT scan), and urine test all with no results on 24Apr2021. The outcome of the events was not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Facial pain, Hypoaesthesia, Malaise
Clinical narrative: Severe muscle pain in left calf; Severe pain at the injection site; stiff Face muscles; joint pain all over my body; Muscle pain all over my body; something just felt off; Numbness in my right foot; loss of sensation in my right foot; Neck sore; cheeks, and jaw felt sore; Dizzy; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old Female patient (Pregnancy at time of Vaccination: No) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 09:15 (Batch/Lot Number: EW0167) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 10:15 AM, the patient developed Severe muscle pain in left calf, Severe pain at the injection site, stiff Face muscles, Muscle and joint pain all over my body, something just felt off, Numbness/loss of sensation in my right foot, Neck sore, cheeks, and jaw felt sore, and Dizzy. The patient was recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 Since the vaccination.   No follow-up attempts are needed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain, Pain in extremity, Sensory loss
Clinical narrative: Severe muscle pain in left calf; Severe pain at the injection site; stiff Face muscles; joint pain all over my body; Muscle pain all over my body; something just felt off; Numbness in my right foot; loss of sensation in my right foot; Neck sore; cheeks, and jaw felt sore; Dizzy; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old Female patient (Pregnancy at time of Vaccination: No) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 09:15 (Batch/Lot Number: EW0167) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 10:15 AM, the patient developed Severe muscle pain in left calf, Severe pain at the injection site, stiff Face muscles, Muscle and joint pain all over my body, something just felt off, Numbness/loss of sensation in my right foot, Neck sore, cheeks, and jaw felt sore, and Dizzy. The patient was recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 Since the vaccination.   No follow-up attempts are needed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe muscle pain in left calf; Severe pain at the injection site; stiff Face muscles; joint pain all over my body; Muscle pain all over my body; something just felt off; Numbness in my right foot; loss of sensation in my right foot; Neck sore; cheeks, and jaw felt sore; Dizzy; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old Female patient (Pregnancy at time of Vaccination: No) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 09:15 (Batch/Lot Number: EW0167) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 10:15 AM, the patient developed Severe muscle pain in left calf, Severe pain at the injection site, stiff Face muscles, Muscle and joint pain all over my body, something just felt off, Numbness/loss of sensation in my right foot, Neck sore, cheeks, and jaw felt sore, and Dizzy. The patient was recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 Since the vaccination.   No follow-up attempts are needed. No further information expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Hearing loud ringing in both ears (tinnitus); This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at 1st dose, single on 25Feb2021 at 13:00 (Lot Number: EN6203, unknown expiration) and at 2nd dose, single on 18Mar2021 at 16:00 (Batch/Lot number was not reported), both via unspecified routes of administration in left arm at the age of 50 years old for COVID-19 immunization. Medical history included fibromyalgia. The patient has unspecified concomitant medication. On 25Feb2021 at 17:00 (about 4 hours after receiving the first dose), the patient started hearing loud ringing in both ears (tinnitus). The event resulted in doctor or other healthcare professional office/clinic visit. The patient was trying hearing aids, but it did not help so far. The ringing is still extremely loud 3 months later. 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 had not yet recovered from the event. The event was assessed as serious (disabling/incapacitating).   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Gait disturbance, Illness
Clinical narrative: body pain; severe fatigue; achy shoulder, neck; achy shoulder, neck; not sleeping well; can't even lift arms up due to the pain; got sick; had no energy; very lethargic; if paitent walks a mile, that's a long walk for patient; lost four to five pounds in the last couple of months; the bottom of feet started to grab and cramp up and hurt; the bottom of feet started to grab and cramp up and hurt; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is third of five reports. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, patient experienced body pain; severe fatigue; achy shoulder, neck; not sleeping well, can't even lift arms up due to the pain, got sick, had no energy, very lethargic, lost four to five pounds in the last couple of months, the bottom of patient feet started to grab and cramp up and hurt. It was reported if patient walks a mile, that's a long walk for patient. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug, similar events, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Mobility decreased, Muscle spasms, Neck pain, Pain
Clinical narrative: body pain; severe fatigue; achy shoulder, neck; achy shoulder, neck; not sleeping well; can't even lift arms up due to the pain; got sick; had no energy; very lethargic; if paitent walks a mile, that's a long walk for patient; lost four to five pounds in the last couple of months; the bottom of feet started to grab and cramp up and hurt; the bottom of feet started to grab and cramp up and hurt; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is third of five reports. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, patient experienced body pain; severe fatigue; achy shoulder, neck; not sleeping well, can't even lift arms up due to the pain, got sick, had no energy, very lethargic, lost four to five pounds in the last couple of months, the bottom of patient feet started to grab and cramp up and hurt. It was reported if patient walks a mile, that's a long walk for patient. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug, similar events, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality sleep, Weight decreased
Clinical narrative: body pain; severe fatigue; achy shoulder, neck; achy shoulder, neck; not sleeping well; can't even lift arms up due to the pain; got sick; had no energy; very lethargic; if paitent walks a mile, that's a long walk for patient; lost four to five pounds in the last couple of months; the bottom of feet started to grab and cramp up and hurt; the bottom of feet started to grab and cramp up and hurt; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is third of five reports. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, patient experienced body pain; severe fatigue; achy shoulder, neck; not sleeping well, can't even lift arms up due to the pain, got sick, had no energy, very lethargic, lost four to five pounds in the last couple of months, the bottom of patient feet started to grab and cramp up and hurt. It was reported if patient walks a mile, that's a long walk for patient. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug, similar events, different patients.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Anaphylactic reaction, Chills, Decreased appetite, Haemorrhage
Clinical narrative: have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat half of what she normally ate; have had off and on spotty bleeding but no monthly period; anaphylaxis reaction; throat to stop feeling like it was closing up; severe headache; sinus pain that felt like someone punched her in the face; all over tingling sensation 20 minutes after getting the shot; chills; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 18Apr2021 13:15 (Batch/Lot Number: ew0151) as 2nd dose, single dose (at the age of 44-years-old) for COVID-19 immunisation. Medical history was not reported. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medication within 2 weeks of vaccination. The patient has not been diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient received his first dose of BNT162B2 on the left arm on 26Mar2021 17:30 (batch/lot number: er8127) for COVID-19 immunisation and experienced extreme structural pain and severe flu like symptoms for 4 days. The patient reported that on the second shot, she had anaphylaxis reaction along with severe headache, sinus pain that felt like someone punched her in the face, and all over tingling sensation 20 minutes after getting the shot. She had to drink 3 doses of BENADRYL for her throat to stop feeling like it was closing up. She then had ringing in her ears, nausea, fever, headache, and chills for 3 days. Since then, she can only eat half of what she normally ate. She has felt nauseated for a month and have had off and on spotty bleeding but no monthly period and a lingering headache that will not go away. The patient has yet to see her doctor due to COVID restrictions. The patient recovered from chills on an unspecified date. The patient has not recovered from headache. The outcome of the remaining events was unknown.   No follow-up attempts are possible. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Paraesthesia, Pyrexia, Sinus pain
Clinical narrative: have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat half of what she normally ate; have had off and on spotty bleeding but no monthly period; anaphylaxis reaction; throat to stop feeling like it was closing up; severe headache; sinus pain that felt like someone punched her in the face; all over tingling sensation 20 minutes after getting the shot; chills; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 18Apr2021 13:15 (Batch/Lot Number: ew0151) as 2nd dose, single dose (at the age of 44-years-old) for COVID-19 immunisation. Medical history was not reported. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medication within 2 weeks of vaccination. The patient has not been diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient received his first dose of BNT162B2 on the left arm on 26Mar2021 17:30 (batch/lot number: er8127) for COVID-19 immunisation and experienced extreme structural pain and severe flu like symptoms for 4 days. The patient reported that on the second shot, she had anaphylaxis reaction along with severe headache, sinus pain that felt like someone punched her in the face, and all over tingling sensation 20 minutes after getting the shot. She had to drink 3 doses of BENADRYL for her throat to stop feeling like it was closing up. She then had ringing in her ears, nausea, fever, headache, and chills for 3 days. Since then, she can only eat half of what she normally ate. She has felt nauseated for a month and have had off and on spotty bleeding but no monthly period and a lingering headache that will not go away. The patient has yet to see her doctor due to COVID restrictions. The patient recovered from chills on an unspecified date. The patient has not recovered from headache. The outcome of the remaining events was unknown.   No follow-up attempts are possible. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tinnitus
Clinical narrative: have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat half of what she normally ate; have had off and on spotty bleeding but no monthly period; anaphylaxis reaction; throat to stop feeling like it was closing up; severe headache; sinus pain that felt like someone punched her in the face; all over tingling sensation 20 minutes after getting the shot; chills; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 18Apr2021 13:15 (Batch/Lot Number: ew0151) as 2nd dose, single dose (at the age of 44-years-old) for COVID-19 immunisation. Medical history was not reported. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medication within 2 weeks of vaccination. The patient has not been diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient received his first dose of BNT162B2 on the left arm on 26Mar2021 17:30 (batch/lot number: er8127) for COVID-19 immunisation and experienced extreme structural pain and severe flu like symptoms for 4 days. The patient reported that on the second shot, she had anaphylaxis reaction along with severe headache, sinus pain that felt like someone punched her in the face, and all over tingling sensation 20 minutes after getting the shot. She had to drink 3 doses of BENADRYL for her throat to stop feeling like it was closing up. She then had ringing in her ears, nausea, fever, headache, and chills for 3 days. Since then, she can only eat half of what she normally ate. She has felt nauseated for a month and have had off and on spotty bleeding but no monthly period and a lingering headache that will not go away. The patient has yet to see her doctor due to COVID restrictions. The patient recovered from chills on an unspecified date. The patient has not recovered from headache. The outcome of the remaining events was unknown.   No follow-up attempts are possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Ejection fraction, Ejection fraction decreased
Clinical narrative: Had a drastically different echocardiogram- his ejection fraction dropped 20%.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included heart history of heart failure and said that 'he died' on 09FEB2016. The patient's concomitant medications were not reported. The patient had a drastically different echocardiogram- his ejection fraction dropped 20% on an unspecified date with outcome of unknown. The patient reported about the Pfizer BioNTech Vaccine clarified as the COVID-19 vaccine. He thought that there were links. He added that he was fine on the vaccine. He wanted to report data he had a medical background in the medical field clarified as health administration. Since he had a heart history they do echocardiograms. The heart failure team at the hospital. He mentioned a drastically different echocardiogram. They did an echocardiogram the year before he got the Pfizer vaccine and then he had an echocardiogram after he got the Pfizer vaccine, the day before last. His ejection fraction dropped 20 percent day before last on an unknown date. He doesn't know why and was establishing a link between myocardia, clarified as inflammation of the heart muscle. He commented that it may not be, could be totally unrelated. The ejection fraction dropped with the Covid vaccine in the middle and a major drop in the ejection fraction. His went from 50% to 25-30%. He wanted to bring it to our attention. The more data it helps, a 20% ejection fraction drop in a heart failure patient is bad but he doesn't feel bad or any different to report. It was mentioned that the second dose of the vaccine was given on 12MAR2021  (lot number: 12MAR2021).   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Seizure, Urinary incontinence
Clinical narrative: Seizures back to back to back/cause him to have more seizures; Wetting himself; This is a spontaneous report from a contactable consumer (patient's father). A 53-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01May2021 (Lot Number: EW0161; Expiration Date: 31Jul2021) as 2nd dose, single for covid-19 immunization (keep him alive and healthy). Medical history included ongoing sugar (diabetes) that was diagnosed with sugar 15 years ago (2005), heavy (overweight) been heavy for years. (biggest at 250 and is down to 236-238 now. It was stated that he lost weight before the shot and they do not know why), ongoing seizure all his life (he has had seizures all life), cholesterol (blood cholesterol abnormal), son that is special needs and high functioning and on vagus nerve apparatus. The patient received the first dose bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) via unknown site on 10Apr2021 (Lot number: EW0158) for Covid-19 immunization. Concomitant medication included unspecified medications for seizures and has a VMS (unspecified). The reporter stated that has a son that is special needs and high functioning. The father stated that he has had seizures all life, so he wanted to know if the shot cause him to have more seizures. The father mentioned that he is having seizures back to back to back and wetting himself. The father does not think this has anything to do with the shot, but his mom does. The reporter mentioned that the patient's mom looked online and saw something that stated it causes seizures. The reporter inquired if there were any reports of having seizures for special needs or anybody. He added that the patient had four seizures back to back in his sleep on May2021. The reported further stated that he has an apparatus that was put in his chest that slows the vagus nerve to seizure activity which he has had it since 2004. It was mentioned that that two weeks ago (May2021) when he was with his mom and last night that the seizures started in his sleep. He also was wetting himself which started two weeks ago (May2021) when he was with his mom. The reporter mentioned that he has blood work every 90 days (unknown date) for seizure medications and cholesterol but does not wish to provide (unknown). The father mentioned that the treatment included the patient taking his medication for his seizures as for the wets himself, he got cleaned up and puts fresh clothes on. The outcome of the event convulsions aggravated was recovered on May2021 while the outcome of the other event was recovered on 12May2021.; Sender's Comments: Based on available information  the reported seizures and urinary incontinence are unrelated to bnt162b2.  These are due to the patient's underlying seizure disorder.  Case will be reassessed if additional information is  received.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: when I go to the bathroom, I have blood coming out; This is a spontaneous report from a contactable consumer (patient). A 44-year-old patient of an unspecified gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EW0172), via an unspecified route of administration, administered in the right deltoid (also reported as right shoulder) on 04May2021 as an unknown dose number, as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported.  After the patient had the vaccine, ever since an unspecified date, the patient reported 'when I go to the bathroom, I have blood coming out'. The patient has not taken any treatment for the event. The outcome of the event was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Inappropriate schedule of product administration
Clinical narrative: I experienced bleeding similar to menstruation; pateint recevied first dose on 02Apr2021 and the second one on 16apr2021; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old non pregnant  female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.Age at vaccination 53 years  . No other medications the patient received within 2 weeks of vaccination. Medical history :menopause.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 on 02Apr2021 at age of 53 years on arm let at 10:30 AM.  The patient's concomitant medications were not reported.  The patient experienced i experienced bleeding similar to menstruation  on 05May2021 with outcome of recovered .The clinical course was reported as follows: I am a post menopausal women. I have been postmenopausal for over 2 years. I experienced bleeding similar to menstruation 2 1/2 weeks after my second vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit.Additional information: the patient was not diagnosed with COVID-19.Since the vaccination,  the patient has not  been tested for COVID-19  Information about Batch/Lot number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Haemorrhage, Headache
Clinical narrative: bleeding; headache; sore throat; cough; dizziness; tiredness; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 05May2021 12:15 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bleeding, headache, sore throat, cough, dizziness, and tiredness on 08May2021. Events were resulted in emergency room/department or urgent care. Treatments included pills and zirup. Nasal swab on 12May2021: Negative. Outcome of the events was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: bleeding; headache; sore throat; cough; dizziness; tiredness; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 05May2021 12:15 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bleeding, headache, sore throat, cough, dizziness, and tiredness on 08May2021. Events were resulted in emergency room/department or urgent care. Treatments included pills and zirup. Nasal swab on 12May2021: Negative. Outcome of the events was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Feeding disorder, Heart rate, Heart rate increased, Weight
Clinical narrative: Heart was beating away fast; Lost a lot of weight; Really bad heartburn; Can't hardly eat; This is a spontaneous report from a contactable consumer. A 5-decade-old female patient (in his 40's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose (1st dose, single dose), with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's was beating away fast; had lost a lot of weight; had a really bad heartburn; and could not hardly eat. The patient was hospitalized on an unspecified date due to the reported events. The outcome of the events was unknown. The patient stated she would not be taking the second dose of vaccination.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Heart was beating away fast; Lost a lot of weight; Really bad heartburn; Can't hardly eat; This is a spontaneous report from a contactable consumer. A 5-decade-old female patient (in his 40's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose (1st dose, single dose), with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's was beating away fast; had lost a lot of weight; had a really bad heartburn; and could not hardly eat. The patient was hospitalized on an unspecified date due to the reported events. The outcome of the events was unknown. The patient stated she would not be taking the second dose of vaccination.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Feeling hot, Ocular hyperaemia, Pharyngeal swelling
Clinical narrative: Hot swollen face red; Hot swollen face red; Have sort of puff in my eardrums and my hearing was like I was in an Echo chamber; Right eye is red; Hot swollen face red; Dizzy; I had extreme tremor in right arm; Had throat swell; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 68-years-old via an unspecified route of administration, administered in arm left on 12May2021 (Batch/Lot Number: ER8735; Expiration Date: 12May2021) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she had her first vaccine and she had throat swell, was dizzy and then had very extreme tremor in her right arm immediately after the vaccine on 12May2021.  She stayed in the supervisory section for about 20 minutes and then they transferred me to an Emergency room. She had very hot swollen face red and now a days after quite a while as she have sort of puff in her eardrums and her hearing was like she was in an Echo chamber on unspecified dates. The patient further reported that her face is red and her right eye is red on unspecified dates. She asked how many milligrams in the vaccine has the Propylene glycol. When probed for vaccine expiration date, consumer stated, it says that date she got it 12May2021 and on sticker it says expired on 12May2021 and queried if she received expired vaccine. The outcome of the events was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tinnitus, Tremor
Clinical narrative: Hot swollen face red; Hot swollen face red; Have sort of puff in my eardrums and my hearing was like I was in an Echo chamber; Right eye is red; Hot swollen face red; Dizzy; I had extreme tremor in right arm; Had throat swell; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 68-years-old via an unspecified route of administration, administered in arm left on 12May2021 (Batch/Lot Number: ER8735; Expiration Date: 12May2021) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she had her first vaccine and she had throat swell, was dizzy and then had very extreme tremor in her right arm immediately after the vaccine on 12May2021.  She stayed in the supervisory section for about 20 minutes and then they transferred me to an Emergency room. She had very hot swollen face red and now a days after quite a while as she have sort of puff in her eardrums and her hearing was like she was in an Echo chamber on unspecified dates. The patient further reported that her face is red and her right eye is red on unspecified dates. She asked how many milligrams in the vaccine has the Propylene glycol. When probed for vaccine expiration date, consumer stated, it says that date she got it 12May2021 and on sticker it says expired on 12May2021 and queried if she received expired vaccine. The outcome of the events was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.