chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Chills, Death, Headache
Clinical narrative: DEATH; BRAIN HEMORRHAGE; FELT TERRIBLE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS; STOMACH ACHE; This spontaneous report received from a consumer concerned a 60-year-old female patient. The patient's height, and weight were not reported. The patient's past medical history included ankle rebuilt (6 or 7 months prior), and brain hemorrhage (root cause unknown), and concurrent conditions included multiple sclerosis (had been traveling prior, and was on active medication), and slightly overweight, and other pre-existing medical conditions included the patient had ankle rebuilt 6 or 7 months prior. The patient was not pregnancy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 (on the day of vaccination), the patient started experiencing stomach ache. On 17-APR-2021 (Saturday), she was experiencing headaches that wouldn't go away/ persistent headache, chills, body aches, pain in pelvis. On 20-APR-2021 (Monday), she complained that she felt terrible. Her doctor recommended her to take Motrin 800mg. On 21-APR-2021 (Wednesday), reporter got a call from a friend saying that patient had passed away likely in her sleep early Wednesday or shortly after waking. According to him, the reason for her death was brain hemorrhage. The medical examiner was still reviewing to ascertain the root cause of the hemorrhage. The patient died from brain hemorrhage, unknown cause of death, stomach ache, persistent headache/ headache would not go away, chills, body aches, and pain in pelvis. On an unspecified date, the autopsy was performed (results unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 21-APR-2021, and the outcome of felt terrible was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000183965. The suspected product quality complaint (PQC) has been confirmed to be voided PQV Management Approval confirmed no PQC was identified within the reported complaint reported. Complaint was approved for void based on the PQC evaluation/investigation performed; Sender's Comments: V0: 20210654540-covid-19 vaccine ad26.cov2.s-Death, brain hemorrhage, stomach, persistent headache/headache would not go away, chills, body aches, pain in pelvis. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BRAIN HEMORRHAGE; UNKNOWN CAUSE OF DEATH; STOMACH ACHE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Cerebral haemorrhage, Chills, Death, Feeling abnormal
Clinical narrative: DEATH; BRAIN HEMORRHAGE; FELT TERRIBLE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS; STOMACH ACHE; This spontaneous report received from a consumer concerned a 60-year-old female patient. The patient's height, and weight were not reported. The patient's past medical history included ankle rebuilt (6 or 7 months prior), and brain hemorrhage (root cause unknown), and concurrent conditions included multiple sclerosis (had been traveling prior, and was on active medication), and slightly overweight, and other pre-existing medical conditions included the patient had ankle rebuilt 6 or 7 months prior. The patient was not pregnancy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 (on the day of vaccination), the patient started experiencing stomach ache. On 17-APR-2021 (Saturday), she was experiencing headaches that wouldn't go away/ persistent headache, chills, body aches, pain in pelvis. On 20-APR-2021 (Monday), she complained that she felt terrible. Her doctor recommended her to take Motrin 800mg. On 21-APR-2021 (Wednesday), reporter got a call from a friend saying that patient had passed away likely in her sleep early Wednesday or shortly after waking. According to him, the reason for her death was brain hemorrhage. The medical examiner was still reviewing to ascertain the root cause of the hemorrhage. The patient died from brain hemorrhage, unknown cause of death, stomach ache, persistent headache/ headache would not go away, chills, body aches, and pain in pelvis. On an unspecified date, the autopsy was performed (results unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 21-APR-2021, and the outcome of felt terrible was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000183965. The suspected product quality complaint (PQC) has been confirmed to be voided PQV Management Approval confirmed no PQC was identified within the reported complaint reported. Complaint was approved for void based on the PQC evaluation/investigation performed; Sender's Comments: V0: 20210654540-covid-19 vaccine ad26.cov2.s-Death, brain hemorrhage, stomach, persistent headache/headache would not go away, chills, body aches, pain in pelvis. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BRAIN HEMORRHAGE; UNKNOWN CAUSE OF DEATH; STOMACH ACHE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Pain, Pelvic pain
Clinical narrative: DEATH; BRAIN HEMORRHAGE; FELT TERRIBLE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS; STOMACH ACHE; This spontaneous report received from a consumer concerned a 60-year-old female patient. The patient's height, and weight were not reported. The patient's past medical history included ankle rebuilt (6 or 7 months prior), and brain hemorrhage (root cause unknown), and concurrent conditions included multiple sclerosis (had been traveling prior, and was on active medication), and slightly overweight, and other pre-existing medical conditions included the patient had ankle rebuilt 6 or 7 months prior. The patient was not pregnancy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 (on the day of vaccination), the patient started experiencing stomach ache. On 17-APR-2021 (Saturday), she was experiencing headaches that wouldn't go away/ persistent headache, chills, body aches, pain in pelvis. On 20-APR-2021 (Monday), she complained that she felt terrible. Her doctor recommended her to take Motrin 800mg. On 21-APR-2021 (Wednesday), reporter got a call from a friend saying that patient had passed away likely in her sleep early Wednesday or shortly after waking. According to him, the reason for her death was brain hemorrhage. The medical examiner was still reviewing to ascertain the root cause of the hemorrhage. The patient died from brain hemorrhage, unknown cause of death, stomach ache, persistent headache/ headache would not go away, chills, body aches, and pain in pelvis. On an unspecified date, the autopsy was performed (results unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 21-APR-2021, and the outcome of felt terrible was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000183965. The suspected product quality complaint (PQC) has been confirmed to be voided PQV Management Approval confirmed no PQC was identified within the reported complaint reported. Complaint was approved for void based on the PQC evaluation/investigation performed; Sender's Comments: V0: 20210654540-covid-19 vaccine ad26.cov2.s-Death, brain hemorrhage, stomach, persistent headache/headache would not go away, chills, body aches, pain in pelvis. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BRAIN HEMORRHAGE; UNKNOWN CAUSE OF DEATH; STOMACH ACHE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Death, Dizziness, Fatigue, Headache
Clinical narrative: DEATH; BRAIN HEMORRHAGE; FELT TERRIBLE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS; STOMACH ACHE; This spontaneous report received from a consumer concerned a 60-year-old female patient. The patient's height, and weight were not reported. The patient's past medical history included ankle rebuilt (6 or 7 months prior), and brain hemorrhage (root cause unknown), and concurrent conditions included multiple sclerosis (had been traveling prior, and was on active medication), and slightly overweight, and other pre-existing medical conditions included the patient had ankle rebuilt 6 or 7 months prior. The patient was not pregnancy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 (on the day of vaccination), the patient started experiencing stomach ache. On 17-APR-2021 (Saturday), she was experiencing headaches that wouldn't go away/ persistent headache, chills, body aches, pain in pelvis. On 20-APR-2021 (Monday), she complained that she felt terrible. Her doctor recommended her to take Motrin 800mg. On 21-APR-2021 (Wednesday), reporter got a call from a friend saying that patient had passed away likely in her sleep early Wednesday or shortly after waking. According to him, the reason for her death was brain hemorrhage. The medical examiner was still reviewing to ascertain the root cause of the hemorrhage. The patient died from brain hemorrhage, unknown cause of death, stomach ache, persistent headache/ headache would not go away, chills, body aches, and pain in pelvis. On an unspecified date, the autopsy was performed (results unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 21-APR-2021, and the outcome of felt terrible was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000183965. The suspected product quality complaint (PQC) has been confirmed to be voided PQV Management Approval confirmed no PQC was identified within the reported complaint reported. Complaint was approved for void based on the PQC evaluation/investigation performed; Sender's Comments: V0: 20210654540-covid-19 vaccine ad26.cov2.s-Death, brain hemorrhage, stomach, persistent headache/headache would not go away, chills, body aches, pain in pelvis. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BRAIN HEMORRHAGE; UNKNOWN CAUSE OF DEATH; STOMACH ACHE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test negative
Clinical narrative: DEATH; BRAIN HEMORRHAGE; FELT TERRIBLE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS; STOMACH ACHE; This spontaneous report received from a consumer concerned a 60-year-old female patient. The patient's height, and weight were not reported. The patient's past medical history included ankle rebuilt (6 or 7 months prior), and brain hemorrhage (root cause unknown), and concurrent conditions included multiple sclerosis (had been traveling prior, and was on active medication), and slightly overweight, and other pre-existing medical conditions included the patient had ankle rebuilt 6 or 7 months prior. The patient was not pregnancy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 (on the day of vaccination), the patient started experiencing stomach ache. On 17-APR-2021 (Saturday), she was experiencing headaches that wouldn't go away/ persistent headache, chills, body aches, pain in pelvis. On 20-APR-2021 (Monday), she complained that she felt terrible. Her doctor recommended her to take Motrin 800mg. On 21-APR-2021 (Wednesday), reporter got a call from a friend saying that patient had passed away likely in her sleep early Wednesday or shortly after waking. According to him, the reason for her death was brain hemorrhage. The medical examiner was still reviewing to ascertain the root cause of the hemorrhage. The patient died from brain hemorrhage, unknown cause of death, stomach ache, persistent headache/ headache would not go away, chills, body aches, and pain in pelvis. On an unspecified date, the autopsy was performed (results unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 21-APR-2021, and the outcome of felt terrible was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000183965. The suspected product quality complaint (PQC) has been confirmed to be voided PQV Management Approval confirmed no PQC was identified within the reported complaint reported. Complaint was approved for void based on the PQC evaluation/investigation performed; Sender's Comments: V0: 20210654540-covid-19 vaccine ad26.cov2.s-Death, brain hemorrhage, stomach, persistent headache/headache would not go away, chills, body aches, pain in pelvis. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BRAIN HEMORRHAGE; UNKNOWN CAUSE OF DEATH; STOMACH ACHE; PERSISTENT HEADACHE/ HEADACHE WOULD NOT GO AWAY; CHILLS; BODY ACHES; PAIN IN PELVIS
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test abnormal, Computerised tomogram abnormal, Erythema, Peripheral swelling
Clinical narrative: 3 days after vaccine pt woke up to swollen arm . Blood clot had developed in left arm.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombectomy, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: 3 days after vaccine pt woke up to swollen arm . Blood clot had developed in left arm.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Peripheral swelling, Thrombectomy, Thrombosis
Clinical narrative: 3 days after vaccine pt woke up to swollen arm . Blood clot had developed in left arm.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose increased, Blood sodium decreased, Blood thyroid stimulating hormone decreased, Breast pain, Chest discomfort
Clinical narrative: runny nose; Sore throat; Breast pain; Constipation; I gained like 4 lbs right after vaccine from a weight I had been at for many years; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 23Mar2021 at single dose for covid-19 immunization.   The patient's medical history included 31 surgeries. Patient was fully disabled and had to retire medically from career at 45 years old. Patient had hashimotos disease in addition to aortic aneurysm, bicuspid valve (causing pvc, pac, random tachycardia), aortic regurgitation, IBS hypertension, interstitial cystitis, degenerative arthritis, fibromyalgia, migraines, degenerative arthritis, MGUS of blood having an M protein, hypothyroidism, bladder disease, asthma, allergies, and many other little things. Patient felt that complications were not being reported although they were happening as confirmed by cardiologist, hematologist, neurologist, and others. She had increased headaches, increased blood pressure issues, many gastrointestinal issues (in fact got a PET scan, CT, urgent care and doctor visits and getting colonoscopy Monday), have had blood drawn many times due to being fatigued, dizziness and WBC, monocytes, basophils, lymphocytes were all out of range and they concluded there appeared to be some type of unidentified infection in body. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. Concomitant medications included clarithromycin (MACROBID [CLARITHROMYCIN]) 10mg daily, amlodipine besilate and losartan. Patient had to increase amlodipine to twice a day and sometimes losartan second dose. On an unspecified date in 2021, patient had a runny nose since vaccine, intermittent episodes of sore throat, breast pain, constipation. Patient gained like 4 lbs right after vaccine from a weight. It has very negatively impacted her life. Patient spent thousands out of pocket on doctor visits, CT scans, urgent care visits, medications. On an unknown date, the patient underwent lab tests and procedures which included Computerised tomogram scan and Positron emission tomogram scan with results of unknown. The outcome of the events was unknown.  No new information received. Follow up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cystitis, Dyspnoea, Fatigue, Full blood count, Hypertension
Clinical narrative: runny nose; Sore throat; Breast pain; Constipation; I gained like 4 lbs right after vaccine from a weight I had been at for many years; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 23Mar2021 at single dose for covid-19 immunization.   The patient's medical history included 31 surgeries. Patient was fully disabled and had to retire medically from career at 45 years old. Patient had hashimotos disease in addition to aortic aneurysm, bicuspid valve (causing pvc, pac, random tachycardia), aortic regurgitation, IBS hypertension, interstitial cystitis, degenerative arthritis, fibromyalgia, migraines, degenerative arthritis, MGUS of blood having an M protein, hypothyroidism, bladder disease, asthma, allergies, and many other little things. Patient felt that complications were not being reported although they were happening as confirmed by cardiologist, hematologist, neurologist, and others. She had increased headaches, increased blood pressure issues, many gastrointestinal issues (in fact got a PET scan, CT, urgent care and doctor visits and getting colonoscopy Monday), have had blood drawn many times due to being fatigued, dizziness and WBC, monocytes, basophils, lymphocytes were all out of range and they concluded there appeared to be some type of unidentified infection in body. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. Concomitant medications included clarithromycin (MACROBID [CLARITHROMYCIN]) 10mg daily, amlodipine besilate and losartan. Patient had to increase amlodipine to twice a day and sometimes losartan second dose. On an unspecified date in 2021, patient had a runny nose since vaccine, intermittent episodes of sore throat, breast pain, constipation. Patient gained like 4 lbs right after vaccine from a weight. It has very negatively impacted her life. Patient spent thousands out of pocket on doctor visits, CT scans, urgent care visits, medications. On an unknown date, the patient underwent lab tests and procedures which included Computerised tomogram scan and Positron emission tomogram scan with results of unknown. The outcome of the events was unknown.  No new information received. Follow up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test abnormal, Metabolic function test, Red blood cell count decreased, Weight increased, White blood cell count increased
Clinical narrative: runny nose; Sore throat; Breast pain; Constipation; I gained like 4 lbs right after vaccine from a weight I had been at for many years; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 23Mar2021 at single dose for covid-19 immunization.   The patient's medical history included 31 surgeries. Patient was fully disabled and had to retire medically from career at 45 years old. Patient had hashimotos disease in addition to aortic aneurysm, bicuspid valve (causing pvc, pac, random tachycardia), aortic regurgitation, IBS hypertension, interstitial cystitis, degenerative arthritis, fibromyalgia, migraines, degenerative arthritis, MGUS of blood having an M protein, hypothyroidism, bladder disease, asthma, allergies, and many other little things. Patient felt that complications were not being reported although they were happening as confirmed by cardiologist, hematologist, neurologist, and others. She had increased headaches, increased blood pressure issues, many gastrointestinal issues (in fact got a PET scan, CT, urgent care and doctor visits and getting colonoscopy Monday), have had blood drawn many times due to being fatigued, dizziness and WBC, monocytes, basophils, lymphocytes were all out of range and they concluded there appeared to be some type of unidentified infection in body. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. Concomitant medications included clarithromycin (MACROBID [CLARITHROMYCIN]) 10mg daily, amlodipine besilate and losartan. Patient had to increase amlodipine to twice a day and sometimes losartan second dose. On an unspecified date in 2021, patient had a runny nose since vaccine, intermittent episodes of sore throat, breast pain, constipation. Patient gained like 4 lbs right after vaccine from a weight. It has very negatively impacted her life. Patient spent thousands out of pocket on doctor visits, CT scans, urgent care visits, medications. On an unknown date, the patient underwent lab tests and procedures which included Computerised tomogram scan and Positron emission tomogram scan with results of unknown. The outcome of the events was unknown.  No new information received. Follow up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breast pain, Computerised tomogram, Constipation, Oropharyngeal pain, Positron emission tomogram
Clinical narrative: runny nose; Sore throat; Breast pain; Constipation; I gained like 4 lbs right after vaccine from a weight I had been at for many years; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 23Mar2021 at single dose for covid-19 immunization.   The patient's medical history included 31 surgeries. Patient was fully disabled and had to retire medically from career at 45 years old. Patient had hashimotos disease in addition to aortic aneurysm, bicuspid valve (causing pvc, pac, random tachycardia), aortic regurgitation, IBS hypertension, interstitial cystitis, degenerative arthritis, fibromyalgia, migraines, degenerative arthritis, MGUS of blood having an M protein, hypothyroidism, bladder disease, asthma, allergies, and many other little things. Patient felt that complications were not being reported although they were happening as confirmed by cardiologist, hematologist, neurologist, and others. She had increased headaches, increased blood pressure issues, many gastrointestinal issues (in fact got a PET scan, CT, urgent care and doctor visits and getting colonoscopy Monday), have had blood drawn many times due to being fatigued, dizziness and WBC, monocytes, basophils, lymphocytes were all out of range and they concluded there appeared to be some type of unidentified infection in body. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. Concomitant medications included clarithromycin (MACROBID [CLARITHROMYCIN]) 10mg daily, amlodipine besilate and losartan. Patient had to increase amlodipine to twice a day and sometimes losartan second dose. On an unspecified date in 2021, patient had a runny nose since vaccine, intermittent episodes of sore throat, breast pain, constipation. Patient gained like 4 lbs right after vaccine from a weight. It has very negatively impacted her life. Patient spent thousands out of pocket on doctor visits, CT scans, urgent care visits, medications. On an unknown date, the patient underwent lab tests and procedures which included Computerised tomogram scan and Positron emission tomogram scan with results of unknown. The outcome of the events was unknown.  No new information received. Follow up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rhinorrhoea, Weight increased
Clinical narrative: runny nose; Sore throat; Breast pain; Constipation; I gained like 4 lbs right after vaccine from a weight I had been at for many years; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 23Mar2021 at single dose for covid-19 immunization.   The patient's medical history included 31 surgeries. Patient was fully disabled and had to retire medically from career at 45 years old. Patient had hashimotos disease in addition to aortic aneurysm, bicuspid valve (causing pvc, pac, random tachycardia), aortic regurgitation, IBS hypertension, interstitial cystitis, degenerative arthritis, fibromyalgia, migraines, degenerative arthritis, MGUS of blood having an M protein, hypothyroidism, bladder disease, asthma, allergies, and many other little things. Patient felt that complications were not being reported although they were happening as confirmed by cardiologist, hematologist, neurologist, and others. She had increased headaches, increased blood pressure issues, many gastrointestinal issues (in fact got a PET scan, CT, urgent care and doctor visits and getting colonoscopy Monday), have had blood drawn many times due to being fatigued, dizziness and WBC, monocytes, basophils, lymphocytes were all out of range and they concluded there appeared to be some type of unidentified infection in body. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. Concomitant medications included clarithromycin (MACROBID [CLARITHROMYCIN]) 10mg daily, amlodipine besilate and losartan. Patient had to increase amlodipine to twice a day and sometimes losartan second dose. On an unspecified date in 2021, patient had a runny nose since vaccine, intermittent episodes of sore throat, breast pain, constipation. Patient gained like 4 lbs right after vaccine from a weight. It has very negatively impacted her life. Patient spent thousands out of pocket on doctor visits, CT scans, urgent care visits, medications. On an unknown date, the patient underwent lab tests and procedures which included Computerised tomogram scan and Positron emission tomogram scan with results of unknown. The outcome of the events was unknown.  No new information received. Follow up attempts are needed. Further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Heart rate increased, Pharyngeal swelling, Urticaria
Clinical narrative: Anaphylaxis; This is a spontaneous report received from a contactable consumer or other non hcp. A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EWU185) via an unspecified route of administration in left arm on 13May2021 at 19:00 (age at vaccination 49 years old, Pregnancy at time of Vaccination: No) as first dose, single for COVID-19 immunization. Medical history included Sjogren's syndrome, Reynauds, Ankylosis, Spondylitis and multi-nodular thyroid. Patient was allergic to Amoxicillin, Lamotrigine, Gabapentin, IV Contrast, peanuts, tree nuts and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included lithium (LITHIUM), cariprazine hydrochloride (VRAYLAR) and amfetamine aspartate monohydrate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (MYDAYIS). Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced anaphylaxis on 13May2021 at 19:00. The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse event in hospital. The patient was hospitalized for anaphylaxis on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This is a spontaneous report received from a contactable consumer or other non hcp. A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EWU185) via an unspecified route of administration in left arm on 13May2021 at 19:00 (age at vaccination 49 years old, Pregnancy at time of Vaccination: No) as first dose, single for COVID-19 immunization. Medical history included Sjogren's syndrome, Reynauds, Ankylosis, Spondylitis and multi-nodular thyroid. Patient was allergic to Amoxicillin, Lamotrigine, Gabapentin, IV Contrast, peanuts, tree nuts and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included lithium (LITHIUM), cariprazine hydrochloride (VRAYLAR) and amfetamine aspartate monohydrate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (MYDAYIS). Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced anaphylaxis on 13May2021 at 19:00. The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse event in hospital. The patient was hospitalized for anaphylaxis on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dissociation, Dizziness, Dysphonia, Hypertension
Clinical narrative: Anaphylaxis; This is a spontaneous report received from a contactable consumer or other non hcp. A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EWU185) via an unspecified route of administration in left arm on 13May2021 at 19:00 (age at vaccination 49 years old, Pregnancy at time of Vaccination: No) as first dose, single for COVID-19 immunization. Medical history included Sjogren's syndrome, Reynauds, Ankylosis, Spondylitis and multi-nodular thyroid. Patient was allergic to Amoxicillin, Lamotrigine, Gabapentin, IV Contrast, peanuts, tree nuts and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included lithium (LITHIUM), cariprazine hydrochloride (VRAYLAR) and amfetamine aspartate monohydrate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (MYDAYIS). Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced anaphylaxis on 13May2021 at 19:00. The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse event in hospital. The patient was hospitalized for anaphylaxis on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Livedo reticularis, Oropharyngeal pain, Sensation of foreign body, Tachycardia
Clinical narrative: Anaphylaxis; This is a spontaneous report received from a contactable consumer or other non hcp. A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EWU185) via an unspecified route of administration in left arm on 13May2021 at 19:00 (age at vaccination 49 years old, Pregnancy at time of Vaccination: No) as first dose, single for COVID-19 immunization. Medical history included Sjogren's syndrome, Reynauds, Ankylosis, Spondylitis and multi-nodular thyroid. Patient was allergic to Amoxicillin, Lamotrigine, Gabapentin, IV Contrast, peanuts, tree nuts and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included lithium (LITHIUM), cariprazine hydrochloride (VRAYLAR) and amfetamine aspartate monohydrate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (MYDAYIS). Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced anaphylaxis on 13May2021 at 19:00. The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse event in hospital. The patient was hospitalized for anaphylaxis on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chronic myeloid leukaemia, Epistaxis, Facial pain, Full blood count normal
Clinical narrative: Arm pain leg cramps,nose bleeds, headaches, dizziness, vertigo  ,loss of sleep
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Joint lock, Muscle spasms, Pain in extremity, Swelling
Clinical narrative: Arm pain leg cramps,nose bleeds, headaches, dizziness, vertigo  ,loss of sleep
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray normal
Clinical narrative: Arm pain leg cramps,nose bleeds, headaches, dizziness, vertigo  ,loss of sleep
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Condition aggravated, Dizziness, Epistaxis, Headache
Clinical narrative: Arm pain leg cramps,nose bleeds, headaches, dizziness, vertigo  ,loss of sleep
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Muscle spasms, Pain in extremity, Sleep disorder, Vertigo
Clinical narrative: Arm pain leg cramps,nose bleeds, headaches, dizziness, vertigo  ,loss of sleep
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Arm pain leg cramps,nose bleeds, headaches, dizziness, vertigo  ,loss of sleep
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: HIVES LOCATED ON RIGHT AND LEFT BUTT CHEEKS WERE MILD AND ITCHY; MILD CHILLS; MILD FATIGUE; TINNITUS; BODY JERKING; FELT LIKE SHE WAS FALLING; CLOGGED SINUS FELT SUPER CLOGGED IN BILATERAL EARS; BODY ACHES WERE MILD AND LOCATED IN THE NECK AND SHOULDERS MOSTLY; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no history of known drug abuse/ illicit. patient is not taking any medications, reports that patient is healthy. patient is not pregnant at the time of vaccination. The patient experienced drug allergy when treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body aches were mild and located in the neck and shoulders mostly. On 13-MAY-2021, the subject experienced tinnitus. On 13-MAY-2021, the subject experienced body jerking. On 13-MAY-2021, the subject experienced felt like she was falling. On 13-MAY-2021, the subject experienced clogged sinus felt super clogged in bilateral ears. On 13-MAY-2021, the subject experienced mild chills. On 13-MAY-2021, the subject experienced mild fatigue. On 14-MAY-2021, the subject experienced hives located on right and left butt cheeks were mild and itchy. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body jerking, and felt like she was falling on 08-JUN-2021, clogged sinus felt super clogged in bilateral ears on JUN-2021, body aches were mild and located in the neck and shoulders mostly on 25-MAY-2021, mild chills, and mild fatigue on 14-MAY-2021, and hives located on right and left butt cheeks were mild and itchy on 12-JUN-2021, and was recovering from tinnitus. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyskinesia, Fatigue, Pain, Sensory disturbance
Clinical narrative: HIVES LOCATED ON RIGHT AND LEFT BUTT CHEEKS WERE MILD AND ITCHY; MILD CHILLS; MILD FATIGUE; TINNITUS; BODY JERKING; FELT LIKE SHE WAS FALLING; CLOGGED SINUS FELT SUPER CLOGGED IN BILATERAL EARS; BODY ACHES WERE MILD AND LOCATED IN THE NECK AND SHOULDERS MOSTLY; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no history of known drug abuse/ illicit. patient is not taking any medications, reports that patient is healthy. patient is not pregnant at the time of vaccination. The patient experienced drug allergy when treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body aches were mild and located in the neck and shoulders mostly. On 13-MAY-2021, the subject experienced tinnitus. On 13-MAY-2021, the subject experienced body jerking. On 13-MAY-2021, the subject experienced felt like she was falling. On 13-MAY-2021, the subject experienced clogged sinus felt super clogged in bilateral ears. On 13-MAY-2021, the subject experienced mild chills. On 13-MAY-2021, the subject experienced mild fatigue. On 14-MAY-2021, the subject experienced hives located on right and left butt cheeks were mild and itchy. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body jerking, and felt like she was falling on 08-JUN-2021, clogged sinus felt super clogged in bilateral ears on JUN-2021, body aches were mild and located in the neck and shoulders mostly on 25-MAY-2021, mild chills, and mild fatigue on 14-MAY-2021, and hives located on right and left butt cheeks were mild and itchy on 12-JUN-2021, and was recovering from tinnitus. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus congestion, Tinnitus, Urticaria
Clinical narrative: HIVES LOCATED ON RIGHT AND LEFT BUTT CHEEKS WERE MILD AND ITCHY; MILD CHILLS; MILD FATIGUE; TINNITUS; BODY JERKING; FELT LIKE SHE WAS FALLING; CLOGGED SINUS FELT SUPER CLOGGED IN BILATERAL EARS; BODY ACHES WERE MILD AND LOCATED IN THE NECK AND SHOULDERS MOSTLY; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no history of known drug abuse/ illicit. patient is not taking any medications, reports that patient is healthy. patient is not pregnant at the time of vaccination. The patient experienced drug allergy when treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body aches were mild and located in the neck and shoulders mostly. On 13-MAY-2021, the subject experienced tinnitus. On 13-MAY-2021, the subject experienced body jerking. On 13-MAY-2021, the subject experienced felt like she was falling. On 13-MAY-2021, the subject experienced clogged sinus felt super clogged in bilateral ears. On 13-MAY-2021, the subject experienced mild chills. On 13-MAY-2021, the subject experienced mild fatigue. On 14-MAY-2021, the subject experienced hives located on right and left butt cheeks were mild and itchy. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body jerking, and felt like she was falling on 08-JUN-2021, clogged sinus felt super clogged in bilateral ears on JUN-2021, body aches were mild and located in the neck and shoulders mostly on 25-MAY-2021, mild chills, and mild fatigue on 14-MAY-2021, and hives located on right and left butt cheeks were mild and itchy on 12-JUN-2021, and was recovering from tinnitus. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid 19; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 27Apr2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He had first dose of the Pfizer Covid vaccine on 27Apr2021 and then tested positive for covid 19 on 2021. He would have completed quarantine before the day of his second dose on 11May2021. Also asking question was it okay for him to still get his second dose of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 2021. The outcome of event was unknown.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Herpes zoster, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On an unspecified date, patient was diagnosed with shingles after being vaccinated with the suspect vaccine. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On an unspecified date, patient was diagnosed with shingles after being vaccinated with the suspect vaccine. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On an unspecified date, patient was diagnosed with shingles after being vaccinated with the suspect vaccine. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: bilateral catharsis; This is a spontaneous report from a contactable consumer (patient) reporting herself.    A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history was concomitant medications not reported.  It was reported, stated, consumer on the line who has experienced a serious adverse reaction according to her and her ophthalmologist said that she had a "bilateral catharsis" (further not clarified). The patient wanted to know if she can get her second dose. She received the first dose of Pfizer Biotech Covid-19 Vaccine on 04Jun2021, and her next dose is tomorrow. Follow-up on (21Jun2021), it was reported that, patient is yet to know if she can get her second dose. The outcome for the event was unknown.  Information on lot/batch number has been requested.