chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Antiphospholipid syndrome, Embolism venous, SARS-CoV-1 test negative
Clinical narrative: Acute embolism & thrombosis right femoral vein; Antiphospholipid; hair loss; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 02:15 (Batch/Lot Number: EL5318) as single dose, for covid-19 immunisation at hospital when 64 years old. Medical history included SI joint, BP and migraines. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ); metoprolol succinate (TOPROL); levothyroxine sodium (SYNTHROID); esomeprazole sodium (NEXIUM); potassium chloride (POTASSIUM CHLORIDE) all 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. On 02Feb2021 13:00 the patient experienced acute embolism & thrombosis right femoral vein, antiphospholipid and hair loss. All the events were serious as life-threatening and hospitalization. The patient was hospitalized for the events for 3 days. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-1 test negative: negative on 29Mar2021 (Nasal Swab). Therapeutic measures were taken as a result of the events and included Warfarin and Lovonox. The outcome of the events was recovered with sequelae in 2021. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number: EL9266) in left arm on 18Feb2021 at 14:00.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Liver function test
Clinical narrative: AST - 476; ALT - 103; LFTs elevation; This is a spontaneous report from a contactable consumer (patient) reported for herself. A non-pregnant 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07May2021 (at age of 20 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included lithium; lamotrigine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunization. LFTs elevation 2 weeks post second dose AST (Aspartate aminotransferase):476, ALT (Alanine aminotransferase): 103, Adverse event start date was 21May2021, came back to normal an additional 2 week after this (on 04Jun2021). No treatment received. The outcome of the events was Recovered on 04Jun2021.  information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test increased
Clinical narrative: AST - 476; ALT - 103; LFTs elevation; This is a spontaneous report from a contactable consumer (patient) reported for herself. A non-pregnant 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07May2021 (at age of 20 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included lithium; lamotrigine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunization. LFTs elevation 2 weeks post second dose AST (Aspartate aminotransferase):476, ALT (Alanine aminotransferase): 103, Adverse event start date was 21May2021, came back to normal an additional 2 week after this (on 04Jun2021). No treatment received. The outcome of the events was Recovered on 04Jun2021.  information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: suspected covid 19; drug ineffective; This is a spontaneous report from a non-contactable consumer (patient daughter) through a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. As per the reporter, her father (orthopedic surgeon) died of covid-19 vaccine on an unspecified date. The patient underwent lab tests and procedures which included had 2 negative PCR test 14 days later. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: suspected covid
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac flutter, Chest X-ray, Electrocardiogram, Fatigue
Clinical narrative: Heartflutterind; Leg pain all the time; Lower legs swelling; Headache; Tired; This is a spontaneous report received from a contactable consumer (patient). A 38-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number was not reported) at vaccination age 38 years as single dose for covid-19 immunisation. Medical history included known allergies: penicillin. Patient was not pregnant. Concomitant medication included lorazepam. Patient experienced Heart flutterind, leg pain all the time, lower legs swelling, Headache, tired, all on 18May2021 07:30 AM. Treatment was received. Lab data included EKG, chest X-ray, multiple blood tests, ultra sound e. Outcome of events were not recovered.  Information about batch/lot number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: Heartflutterind; Leg pain all the time; Lower legs swelling; Headache; Tired; This is a spontaneous report received from a contactable consumer (patient). A 38-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number was not reported) at vaccination age 38 years as single dose for covid-19 immunisation. Medical history included known allergies: penicillin. Patient was not pregnant. Concomitant medication included lorazepam. Patient experienced Heart flutterind, leg pain all the time, lower legs swelling, Headache, tired, all on 18May2021 07:30 AM. Treatment was received. Lab data included EKG, chest X-ray, multiple blood tests, ultra sound e. Outcome of events were not recovered.  Information about batch/lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dry skin, Dysstasia, Fatigue, Feeling cold
Clinical narrative: severe dehydration; extreme exhaustion and extreme fatigue; high heart palpitations; high blood pressure; cold sensation all over the body; I had trouble standing for long periods of time; My skin became so dry especially on the face.; hair became very dry and brittle.; hair became very dry and brittle.; trouble sleeping because of these symptoms; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6206) via an unspecified route of administration, administered in right arm on 10Mar2021 at 08:30 (at 37 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included shrimp allergy from unspecified date. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Mar2021 at 08:00, the patient experienced severe dehydration, extreme exhaustion and extreme fatigue, high heart palpitations, high blood pressure (was never diagnosed before the vaccination), cold sensation all over the body, trouble sleeping because of these symptoms, trouble standing for long periods of time, skin became so dry especially on the face, and hair became very dry and brittle. The events resulted in physician office visit. The events were considered non-serious. Course of events was reported as follows:  the patient experienced severe dehydration, extreme exhaustion and extreme fatigue. She had high heart palpitations, high blood pressure (was never diagnosed with before the vaccination), cold sensation all over the body. The patient had trouble sleeping because of these symptoms and feared that wouldn't wake up because the palpitations were so high and rapid. The patient had trouble standing for long periods of time. Her skin became so dry especially on the face. Her hair became very dry and brittle. She had to take a few weeks off work due to the symptoms stated above. Treatment received included calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate (PEDIALYTE) for dehydration. Since the vaccination, the patient was tested for COVID-19 which included nasal swab on 18Mar2021 and 14Mar2021 which were negative. Outcome of the events was recovered on unspecified date in 2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hair texture abnormal, Hypertension, Palpitations, Poor quality sleep, Smear test
Clinical narrative: severe dehydration; extreme exhaustion and extreme fatigue; high heart palpitations; high blood pressure; cold sensation all over the body; I had trouble standing for long periods of time; My skin became so dry especially on the face.; hair became very dry and brittle.; hair became very dry and brittle.; trouble sleeping because of these symptoms; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6206) via an unspecified route of administration, administered in right arm on 10Mar2021 at 08:30 (at 37 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included shrimp allergy from unspecified date. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Mar2021 at 08:00, the patient experienced severe dehydration, extreme exhaustion and extreme fatigue, high heart palpitations, high blood pressure (was never diagnosed before the vaccination), cold sensation all over the body, trouble sleeping because of these symptoms, trouble standing for long periods of time, skin became so dry especially on the face, and hair became very dry and brittle. The events resulted in physician office visit. The events were considered non-serious. Course of events was reported as follows:  the patient experienced severe dehydration, extreme exhaustion and extreme fatigue. She had high heart palpitations, high blood pressure (was never diagnosed with before the vaccination), cold sensation all over the body. The patient had trouble sleeping because of these symptoms and feared that wouldn't wake up because the palpitations were so high and rapid. The patient had trouble standing for long periods of time. Her skin became so dry especially on the face. Her hair became very dry and brittle. She had to take a few weeks off work due to the symptoms stated above. Treatment received included calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate (PEDIALYTE) for dehydration. Since the vaccination, the patient was tested for COVID-19 which included nasal swab on 18Mar2021 and 14Mar2021 which were negative. Outcome of the events was recovered on unspecified date in 2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Trichorrhexis
Clinical narrative: severe dehydration; extreme exhaustion and extreme fatigue; high heart palpitations; high blood pressure; cold sensation all over the body; I had trouble standing for long periods of time; My skin became so dry especially on the face.; hair became very dry and brittle.; hair became very dry and brittle.; trouble sleeping because of these symptoms; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6206) via an unspecified route of administration, administered in right arm on 10Mar2021 at 08:30 (at 37 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included shrimp allergy from unspecified date. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Mar2021 at 08:00, the patient experienced severe dehydration, extreme exhaustion and extreme fatigue, high heart palpitations, high blood pressure (was never diagnosed before the vaccination), cold sensation all over the body, trouble sleeping because of these symptoms, trouble standing for long periods of time, skin became so dry especially on the face, and hair became very dry and brittle. The events resulted in physician office visit. The events were considered non-serious. Course of events was reported as follows:  the patient experienced severe dehydration, extreme exhaustion and extreme fatigue. She had high heart palpitations, high blood pressure (was never diagnosed with before the vaccination), cold sensation all over the body. The patient had trouble sleeping because of these symptoms and feared that wouldn't wake up because the palpitations were so high and rapid. The patient had trouble standing for long periods of time. Her skin became so dry especially on the face. Her hair became very dry and brittle. She had to take a few weeks off work due to the symptoms stated above. Treatment received included calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate (PEDIALYTE) for dehydration. Since the vaccination, the patient was tested for COVID-19 which included nasal swab on 18Mar2021 and 14Mar2021 which were negative. Outcome of the events was recovered on unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: She has been experiencing "the most painful periods in her life" since April.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot Number: EP6955) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's Medical history included Lyme disease from an unknown date. Pregnancy at time of Vaccination : No. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No, Prior to vaccination, was the patient diagnosed with COVID-19?: No, Since the vaccination, has the patient been tested for COVID-19?: No. The patient's concomitant medications were not reported. On Apr2021 patient experienced she has been experiencing "the most painful periods in her life" since april. The Outcome for the event was unknown.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Feeling hot, Muscle rigidity, Mydriasis, Nervousness
Clinical narrative: Pupils dilated and he couldn't see.; Pupils dilated and he couldn't see.; shaky; rigid; and was very hot to touch; This is a spontaneous report from a non-contactable consumer (patient). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0202), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jun2021 (at the age of 15-years-old) as dose 1, single for COVID-19 immunization. No medical history was reported. Patient had no known allergy. Other medical history was none. No concomitant medication was reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced pupils dilated and could not see, shaky, rigid, and was very hot to touch on 05Jun2021. This was within a few minutes of receiving the vaccine and lasted about 20-30 minutes. Seriousness criteria was reported as no. As AE treatment, Pharmacist used cold compresses and gave him juice. The outcome of the events were recovered on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 test, Thrombosis
Clinical narrative: I have a blood clot in my left leg that is unprovoked /  The clot runs from poplioteal to common iliac.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 12:00 (at the age of 38-years-old) as dose 2, single for covid-19 immunisation at pharmacy or drug Store. The patient medical history included none. Concomitant medications included lamotrigine (LAMICTAL), vortioxetine hydrobromide (TRINTELLIX). Other medications the patient received within 2 weeks of vaccination included Lamictal, Trintellix. The patient historical vaccine included first dose of BNT162B2 via route of administration, administered in left arm on 08Mar2021 05:00PM (at the age of 38-Years-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. It was reported that, on 21Jun2021 07:00 the patient had a blood clot in his left leg that is unprovoked and he had no underlying conditions. He is male and 38 years old. Blood tests haven't shown the underlying cause and I'm being seen by hemotoligists. The clot runs from poplioteal to common iliac. He was  having a thrombectomy on Monday. The patient was hospitalized for I have a blood clot in my left leg that is unprovoked/the clot runs from poplioteal to common iliac for 7 days. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, sars-cov-2 test: negative on 22Jun2021 (Nasal Swab).  Therapeutic measures were taken as a result of I have a blood clot in my left leg that is unprovoked/the clot runs from poplioteal to common iliac. Heparin was received as treatment for the adverse event. Will have to have a thrombectomy. The reporter assessed the seriousness as serious. Seriousness criteria caused hospitalization. The outcome of the event was reported as not resolved.  Information about batch/Lot number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: blood pressure became elevated; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Mar2021 (at the age of 56-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date (at the age of 56-years-old) for covid-19 immunisation. The patient experienced blood pressure became elevated on 20Mar2021. The reporter stated that he have never had a high blood pressure and he did not have high blood pressure before the vaccine after he receive the vaccine he monitor him blood pressure on a regular basis and his blood pressure became elevated he went to him doctor and confirms that indeed his blood pressure was elevated and a there was nothing that had changed in his lifestyle that would have caused that other than the taking of the vaccine mmm this lasted for about a month and a half and he went back to his doctor after the vaccine the second dose of the vaccine and his blood pressure had come down to normal levels so he believe that the vaccine created some type of reaction the cause me to have high Blood pressure. perhaps information of the heart. His cardiologist who he went to him doctor believes that it is the vaccine that is the reason that his blood pressure was elevated after the backs vaccine and then about a month and a half later it was it came back down. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 20Mar2021 he receive the vaccine he monitor him blood pressure on a regular basis and his blood pressure became elevated, blood pressure measurement: came back down on 05May2021. The outcome of the event was reported as resolved on 05May2021.   Information about lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure became elevated; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Mar2021 (at the age of 56-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date (at the age of 56-years-old) for covid-19 immunisation. The patient experienced blood pressure became elevated on 20Mar2021. The reporter stated that he have never had a high blood pressure and he did not have high blood pressure before the vaccine after he receive the vaccine he monitor him blood pressure on a regular basis and his blood pressure became elevated he went to him doctor and confirms that indeed his blood pressure was elevated and a there was nothing that had changed in his lifestyle that would have caused that other than the taking of the vaccine mmm this lasted for about a month and a half and he went back to his doctor after the vaccine the second dose of the vaccine and his blood pressure had come down to normal levels so he believe that the vaccine created some type of reaction the cause me to have high Blood pressure. perhaps information of the heart. His cardiologist who he went to him doctor believes that it is the vaccine that is the reason that his blood pressure was elevated after the backs vaccine and then about a month and a half later it was it came back down. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 20Mar2021 he receive the vaccine he monitor him blood pressure on a regular basis and his blood pressure became elevated, blood pressure measurement: came back down on 05May2021. The outcome of the event was reported as resolved on 05May2021.   Information about lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood test
Clinical narrative: blood pressure became elevated; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Mar2021 (at the age of 56-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date (at the age of 56-years-old) for covid-19 immunisation. The patient experienced blood pressure became elevated on 20Mar2021. The reporter stated that he have never had a high blood pressure and he did not have high blood pressure before the vaccine after he receive the vaccine he monitor him blood pressure on a regular basis and his blood pressure became elevated he went to him doctor and confirms that indeed his blood pressure was elevated and a there was nothing that had changed in his lifestyle that would have caused that other than the taking of the vaccine mmm this lasted for about a month and a half and he went back to his doctor after the vaccine the second dose of the vaccine and his blood pressure had come down to normal levels so he believe that the vaccine created some type of reaction the cause me to have high Blood pressure. perhaps information of the heart. His cardiologist who he went to him doctor believes that it is the vaccine that is the reason that his blood pressure was elevated after the backs vaccine and then about a month and a half later it was it came back down. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 20Mar2021 he receive the vaccine he monitor him blood pressure on a regular basis and his blood pressure became elevated, blood pressure measurement: came back down on 05May2021. The outcome of the event was reported as resolved on 05May2021.   Information about lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Near death experience, Palpitations
Clinical narrative: She thought she might die; Felt a bit strange and wasn't sure what she was feeling.; feeling her heart beating really hard she felt it from her hips, trunk up to breasts/ chest.; This is a spontaneous report from a contactable consumer (patient).  A 79-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 16:30 (Batch/Lot Number: EW0173; Expiration Date: Aug2021) as 0.3 ml, single dose for covid-19 immunisation at the age of 79-year-old. Medical history included ongoing diabetes, ongoing joint injury, She had a need for knee surgery. The patient has never had any vaccines in her life, not the flu shot or measles or anything. There were no concomitant medications. On 06May2021, the patient felt a bit strange and wasn't sure what she was feeling, feeling her heart beating really hard she felt it from her hips, trunk up to breasts/ chest and thought she might die.  The events felt a bit strange and wasn't sure what she was feeling, feeling her heart beating really hard she felt it from her hips were recovered on 06May2021, outcome of thought she might die was unknown. The events didn't result in visit to Emergency Room or Physician Office. She received the dose 2 (Lot EW0182, EXP date Aug2021) on 27May2021.  The clinical course was reported as: after she received the vaccine she stayed around 30 minutes and seemed ok so she left. She received her shot at 4:30 pm and after she got home she decided she wouldn't know what to do if she had side effects so she decided to lay down on her bed. She states she thought she felt a bit strange and she wasn't sure what she was feeling. After 3 and half hours, while laying on her back, she describes feeling her heart beating really hard she felt it from her hips to the trunk, up to breasts/ chest. Her heart was beating so hard, like thump thump thump, it did not get fast or slow, it was just steady. It was beating so hard that she could feel is shake the bed that she was laying on. The patient stated the doctor has already been informed about her events. She states she didn't call anyone because she thought she might die and she was afraid to move to call. She told herself to just relax, relax, relax so the stress wouldn't bother her. She states the events lasted 3-4 hours but scared to pieces and she was to scared to reach for the phone. she did not go to the doctor about it but told her doctor about it during her check up a couple weeks later and she did routine labs but not for that. She states she is a diabetic. She states she lives alone and is a relatively new widow. The patient stated she has never had any vaccines in her life, not the flu shot or measles or anything.  Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Anosmia, Back pain, Decreased appetite, Diarrhoea
Clinical narrative: Continued GI symptoms; bloating; no appetite; smells not present or identifiable; Increased back pain; runs; This is a spontaneous report from a contactable consumer (patient).   A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration, in the left arm on 16Apr2021 12:00 (at age of 61-year-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing (hypertension) HTN, chronic severe l side spinal pain s/p T10-12 laminectomy, fusion and graft from r hip. Had colonoscopy/endoscopy on 27May2021with polyp removal and some gastritis. Although she continued with the symptoms, weight loss, and weird smells. Known allergies were not reported. The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination was yes but not specified. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, in the left arm on 23Mar2021 12:45 (at age of 61-year-old) as dose 1, single for covid-19 immunisation. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced continued GI symptoms, bloating, runs, no appetite, smells not present or identifiable. Increased back pain after Feb surgery. Seriousness criteria not reported. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient had received treatment for event was increase pain medication and contacted GI docs. Outcome of all events was recovered with sequelae in 2021.  Follow-up actions are needed. Further information has been requested
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: Continued GI symptoms; bloating; no appetite; smells not present or identifiable; Increased back pain; runs; This is a spontaneous report from a contactable consumer (patient).   A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration, in the left arm on 16Apr2021 12:00 (at age of 61-year-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing (hypertension) HTN, chronic severe l side spinal pain s/p T10-12 laminectomy, fusion and graft from r hip. Had colonoscopy/endoscopy on 27May2021with polyp removal and some gastritis. Although she continued with the symptoms, weight loss, and weird smells. Known allergies were not reported. The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination was yes but not specified. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, in the left arm on 23Mar2021 12:45 (at age of 61-year-old) as dose 1, single for covid-19 immunisation. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced continued GI symptoms, bloating, runs, no appetite, smells not present or identifiable. Increased back pain after Feb surgery. Seriousness criteria not reported. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient had received treatment for event was increase pain medication and contacted GI docs. Outcome of all events was recovered with sequelae in 2021.  Follow-up actions are needed. Further information has been requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash erythematous, Rash macular, Rash papular
Clinical narrative: she is breaking out in the full, red-pox all over the place, itching and burning issues.; Breaking out with red bumps all over the place; she is breaking out in the full, red-pox all over the place, itching and burning issues.; she is breaking out in the full, red-pox all over the place, itching and burning issues.; she is breaking out in the full, red-pox all over the place, itching and burning issues.; Breaking out with red bumps all over the place; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient (reporter's mother) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and expiry date was not reported) dose number unknown, via an unspecified route of administration in Arm Left on an unspecified date at 13:00 as single dose for COVID-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No prior vaccination within 4 weeks. On an unspecified date, she is breaking out in the full, red pox all over the place, itching and burning issues and breaking out with red bumps all over the place. Patient got the vaccination shot about a week ago. Reporter stated, was trying to see what she needed to do. Therapeutic measures were not taken as a result of the events. The outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: she is breaking out in the full, red-pox all over the place, itching and burning issues.; Breaking out with red bumps all over the place; she is breaking out in the full, red-pox all over the place, itching and burning issues.; she is breaking out in the full, red-pox all over the place, itching and burning issues.; she is breaking out in the full, red-pox all over the place, itching and burning issues.; Breaking out with red bumps all over the place; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient (reporter's mother) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and expiry date was not reported) dose number unknown, via an unspecified route of administration in Arm Left on an unspecified date at 13:00 as single dose for COVID-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No prior vaccination within 4 weeks. On an unspecified date, she is breaking out in the full, red pox all over the place, itching and burning issues and breaking out with red bumps all over the place. Patient got the vaccination shot about a week ago. Reporter stated, was trying to see what she needed to do. Therapeutic measures were not taken as a result of the events. The outcome of the events was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Persisting rash on inner left arm and inner right thigh; This is a spontaneous report received from a contactable consumer (Patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 05Apr2021 single dose for covid-19 immunisation. Medical history included hyperthyroidism. Patient had no known allergies. There were no concomitant medications (No other medications in two weeks). Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) for covid-19 immunization. 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 been tested for COVID-19 Since the vaccination. On 07Apr2021, the patient experienced persisting rash on inner left arm and inner right thigh. No treatment was received due to adverse events. The event was Recovered/Resolved with Sequel on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she had pain at the injection site and so did her entire family; This is a spontaneous report from a contactable consumer, the mother of the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in Arm on 01Jun2021, as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, on an unknown date in Jun2021, the patient experienced pain at the injection site and so did her entire family but had that pain for 2 days and then it went away. The mother also reported that, if they could educate her daughter at home, she would not have taken the shot, but they decided to take it as a family. She also told she did not do well with vaccines but she could not stomach giving her daughter a vaccine that she would not take. She said, She did not want daughter to get it, completely blind and had to go to school to be educated, not comfort. The outcome of the event was recovered on an unspecified date in Jun2021.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021785013 same reporter/drug, different patient.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash around my upper body; Itchy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 08Jun2021 (Lot Number: EW0186; Expiration Date: Unknown) at the age of 27-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were none. Prior Vaccinations (within 4 weeks), the patient stated none. Investigation assessment was none.  On 24Jun2021, after 16 days after the first shot, the patient experienced rash around upper body and it was not just around the vaccine site, the patient became itchy and was just wondering if anybody else has these side effects and wanted to check if anybody else had something similar to that. And both event serious as medically significant. The patient took a Claritin, and an allergy medication, antihistamine Claritin pill as treatment for events. The patient stated that it could be totally unrelated to the vaccine. The scheduled date for second dose will on 30Jun2021. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: Got very ill from the second dose of the Covid-19 vaccine; This is a spontaneous report from a contactable consumer (daughter in law). A male patient (Husband's father) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 (Received Covid-19 vaccine less than 90 days after Covid-19 infection). The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 for covid-19 immunisation. Caller reported that her husband's father, the patient, was sent to the hospital after he received the second Pfizer Covid-19 vaccine. Caller reported that the patient got very ill from it. The patient had already had Covid while in a facility in (address withheld).  Caller reported that the facility didn't wait 90 days after the patient had a Covid-19 infection before giving him the Covid-19 vaccine. Caller reported that the second Covid-19 vaccine totally messed the patient up and he still had not recovered. The event was serious with seriousness criteria-Caused/prolonged hospitalization. Reporter seriousness for "got very ill from the second dose of the Covid-19 vaccine" was hospitalization. The patient underwent lab tests and procedures which included Covid-19 test on an unknown date with result positive. Event outcome was not recovered.    Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Received first dose Pfizer Covid 19 Vaccine and after that developed Covid.; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program . A 73-year-old female patient started to receive first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EJ6789), dose 1 via an unspecified route of administration on 11Mar2021 (age at the vaccination 73-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced the caller states her husband tested positive for covid/the caller then tested for covid and also tested positive. On 17Mar2021, received first dose pfizer covid 19 vaccine and after that developed covid on 17Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive. The caller then tested for Covid and also tested positive. The outcome of events was Unknown. Follow-up attempts are possible. Information on Lot/Batch number was available.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Dyspepsia, Memory impairment, Rash
Clinical narrative: broke out in a rash; indigestion; pain in his stomach; lost 20 lbs because he can't eat; lightheaded; his memory is shot; This is a spontaneous report from a pharmaceutical company by Pfizer from a contactable consumer or other non hcp. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced broke out in a rash, indigestion, pain in his stomach, lost 20 lbs because he can't eat, lightheaded, his memory is shot. It was reported, the 73 years old male patient reportedly experienced he broke out in a rash and all the while he was having indigestion. The dermatologist healed the rash, but the indigestion continued and about the third or fourth week of April he stared to get pain in his stomach, and it's gotten worse and worse. He has lost 20 lbs because he can't eat. He is lightheaded. and his memory is shot. The clinical outcome for the event broke out in a rash was recovered on an unknown date while event indigestion was not recovered and rest all events were unknown.   No follow-up attempts are possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: broke out in a rash; indigestion; pain in his stomach; lost 20 lbs because he can't eat; lightheaded; his memory is shot; This is a spontaneous report from a pharmaceutical company by Pfizer from a contactable consumer or other non hcp. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced broke out in a rash, indigestion, pain in his stomach, lost 20 lbs because he can't eat, lightheaded, his memory is shot. It was reported, the 73 years old male patient reportedly experienced he broke out in a rash and all the while he was having indigestion. The dermatologist healed the rash, but the indigestion continued and about the third or fourth week of April he stared to get pain in his stomach, and it's gotten worse and worse. He has lost 20 lbs because he can't eat. He is lightheaded. and his memory is shot. The clinical outcome for the event broke out in a rash was recovered on an unknown date while event indigestion was not recovered and rest all events were unknown.   No follow-up attempts are possible. No further information expected.