chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Contusion, Cough, Decreased appetite, Feeling hot
Clinical narrative: LOSS OF APPETITE; REALLY ILL; LACK OF TASTE; COULD NOT WALK DUE TO PAIN; LEG FELT LIKE IT WAS BURNING; BLOOD CLOT; This spontaneous report received from a patient concerned a female of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 180890 expiry: 20-JUN-2021) dose was not reported, 1 total, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, about 30 minutes after the vaccination, the patient noticed her ankle bruising that started to hurt real bad. The entire ankle and part of her leg was severely bruised due to the blood clot in her leg as diagnosed by her doctor. The bruised changed her life for the worse and was extremely embarrassing. It still hurts when the site was touched. The doctor told the patient that her bruise was going to be permanent. On an unspecified date, the patient experienced loss of appetite, as if she got the virus and was really ill, lack of taste (could not taste anymore), could not walk due to pain The doctor was trying to break up the dry blood. Her leg felt at one point like it was burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of appetite and lack of taste, and the outcome of blood clot, really ill, could not walk due to pain and leg felt like it was burning was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210605693-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Nausea, Skin discolouration, Vomiting
Clinical narrative: LOSS OF APPETITE; REALLY ILL; LACK OF TASTE; COULD NOT WALK DUE TO PAIN; LEG FELT LIKE IT WAS BURNING; BLOOD CLOT; This spontaneous report received from a patient concerned a female of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 180890 expiry: 20-JUN-2021) dose was not reported, 1 total, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, about 30 minutes after the vaccination, the patient noticed her ankle bruising that started to hurt real bad. The entire ankle and part of her leg was severely bruised due to the blood clot in her leg as diagnosed by her doctor. The bruised changed her life for the worse and was extremely embarrassing. It still hurts when the site was touched. The doctor told the patient that her bruise was going to be permanent. On an unspecified date, the patient experienced loss of appetite, as if she got the virus and was really ill, lack of taste (could not taste anymore), could not walk due to pain The doctor was trying to break up the dry blood. Her leg felt at one point like it was burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of appetite and lack of taste, and the outcome of blood clot, really ill, could not walk due to pain and leg felt like it was burning was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210605693-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Burning sensation, Decreased appetite, Gait disturbance, Illness
Clinical narrative: LOSS OF APPETITE; REALLY ILL; LACK OF TASTE; COULD NOT WALK DUE TO PAIN; LEG FELT LIKE IT WAS BURNING; BLOOD CLOT; This spontaneous report received from a patient concerned a female of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 180890 expiry: 20-JUN-2021) dose was not reported, 1 total, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, about 30 minutes after the vaccination, the patient noticed her ankle bruising that started to hurt real bad. The entire ankle and part of her leg was severely bruised due to the blood clot in her leg as diagnosed by her doctor. The bruised changed her life for the worse and was extremely embarrassing. It still hurts when the site was touched. The doctor told the patient that her bruise was going to be permanent. On an unspecified date, the patient experienced loss of appetite, as if she got the virus and was really ill, lack of taste (could not taste anymore), could not walk due to pain The doctor was trying to break up the dry blood. Her leg felt at one point like it was burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of appetite and lack of taste, and the outcome of blood clot, really ill, could not walk due to pain and leg felt like it was burning was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210605693-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: LOSS OF APPETITE; REALLY ILL; LACK OF TASTE; COULD NOT WALK DUE TO PAIN; LEG FELT LIKE IT WAS BURNING; BLOOD CLOT; This spontaneous report received from a patient concerned a female of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 180890 expiry: 20-JUN-2021) dose was not reported, 1 total, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, about 30 minutes after the vaccination, the patient noticed her ankle bruising that started to hurt real bad. The entire ankle and part of her leg was severely bruised due to the blood clot in her leg as diagnosed by her doctor. The bruised changed her life for the worse and was extremely embarrassing. It still hurts when the site was touched. The doctor told the patient that her bruise was going to be permanent. On an unspecified date, the patient experienced loss of appetite, as if she got the virus and was really ill, lack of taste (could not taste anymore), could not walk due to pain The doctor was trying to break up the dry blood. Her leg felt at one point like it was burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of appetite and lack of taste, and the outcome of blood clot, really ill, could not walk due to pain and leg felt like it was burning was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210605693-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Loss of control of legs, Mobility decreased
Clinical narrative: leg weakness; This is a spontaneous report from a contactable physicians (one is the patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), at the age of 84-years-old, intramuscular on 23Mar2021 12:15 at 1st dose, single; then intramuscular on 13Apr2021 12:15 at 2nd dose, single in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no family medical history. On 23Mar2021 at 1am, the patient experienced leg weakness. This event required visit to emergency room for 7 hours and was hospitalized on an unspecified date in 2021. The patient received no treatment for treatment and recovered on 23Mar2021. On 13Apr2021 12:15, the patient again experienced leg weakness. The patient was hospitalized for 2 days. It was unknown if the patient received treatment for this. It was also reported that a catheter was inserted for 3 days and repeated again on 26Apr2021. The event was assessed as serious due to disability and hospitalization. It was reported that the vaccine was not administered at military facility. Outcome of the event was reported as not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relation (event occurred after first and second dose administration) there is reasonable possibility of causal association between the event lower extremity weakness and the suspect drug BN162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: leg weakness; This is a spontaneous report from a contactable physicians (one is the patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), at the age of 84-years-old, intramuscular on 23Mar2021 12:15 at 1st dose, single; then intramuscular on 13Apr2021 12:15 at 2nd dose, single in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no family medical history. On 23Mar2021 at 1am, the patient experienced leg weakness. This event required visit to emergency room for 7 hours and was hospitalized on an unspecified date in 2021. The patient received no treatment for treatment and recovered on 23Mar2021. On 13Apr2021 12:15, the patient again experienced leg weakness. The patient was hospitalized for 2 days. It was unknown if the patient received treatment for this. It was also reported that a catheter was inserted for 3 days and repeated again on 26Apr2021. The event was assessed as serious due to disability and hospitalization. It was reported that the vaccine was not administered at military facility. Outcome of the event was reported as not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relation (event occurred after first and second dose administration) there is reasonable possibility of causal association between the event lower extremity weakness and the suspect drug BN162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Blood test, Confusional state, Disorientation
Clinical narrative: NEUROLOGICAL SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced neurological side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological side effect was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Electric shock sensation, Full blood count, Headache, Hypoaesthesia, Magnetic resonance imaging head
Clinical narrative: NEUROLOGICAL SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced neurological side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological side effect was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Neck pain, Nerve conduction studies, Paraesthesia
Clinical narrative: NEUROLOGICAL SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced neurological side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological side effect was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nervous system disorder
Clinical narrative: NEUROLOGICAL SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced neurological side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological side effect was not reported. This report was non-serious.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: 3/10/21 experienced fever, body aches, sore arm.  3/17/21 bilateral hand weakness 4/8/21 2nd injection.  4/9/21 fever, body aches, pain in shoulders, elbows, wrists - very intense felt like on fire.   4/18/21 seen in local ER - joint pain over a month.  given toradol and prednisone by PCP.   5/18/21 Returned to ER with complaints of bilateral arm, shoulder and wrist pain since COVID vaccines.  Given prednisone. His primary care physician has done complete work up and feels patients complaints are due to vaccine.  6/10/21 Spoke to patient still has weakness bilateral hands and arms and constant muscle aches.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Arthralgia, Bone scan abnormal, Burning sensation, Computerised tomogram abdomen normal
Clinical narrative: 3/10/21 experienced fever, body aches, sore arm.  3/17/21 bilateral hand weakness 4/8/21 2nd injection.  4/9/21 fever, body aches, pain in shoulders, elbows, wrists - very intense felt like on fire.   4/18/21 seen in local ER - joint pain over a month.  given toradol and prednisone by PCP.   5/18/21 Returned to ER with complaints of bilateral arm, shoulder and wrist pain since COVID vaccines.  Given prednisone. His primary care physician has done complete work up and feels patients complaints are due to vaccine.  6/10/21 Spoke to patient still has weakness bilateral hands and arms and constant muscle aches.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax, Full blood count normal, Muscular weakness, Myalgia, Pain
Clinical narrative: 3/10/21 experienced fever, body aches, sore arm.  3/17/21 bilateral hand weakness 4/8/21 2nd injection.  4/9/21 fever, body aches, pain in shoulders, elbows, wrists - very intense felt like on fire.   4/18/21 seen in local ER - joint pain over a month.  given toradol and prednisone by PCP.   5/18/21 Returned to ER with complaints of bilateral arm, shoulder and wrist pain since COVID vaccines.  Given prednisone. His primary care physician has done complete work up and feels patients complaints are due to vaccine.  6/10/21 Spoke to patient still has weakness bilateral hands and arms and constant muscle aches.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: 3/10/21 experienced fever, body aches, sore arm.  3/17/21 bilateral hand weakness 4/8/21 2nd injection.  4/9/21 fever, body aches, pain in shoulders, elbows, wrists - very intense felt like on fire.   4/18/21 seen in local ER - joint pain over a month.  given toradol and prednisone by PCP.   5/18/21 Returned to ER with complaints of bilateral arm, shoulder and wrist pain since COVID vaccines.  Given prednisone. His primary care physician has done complete work up and feels patients complaints are due to vaccine.  6/10/21 Spoke to patient still has weakness bilateral hands and arms and constant muscle aches.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Pyrexia
Clinical narrative: fevers, chills, HA, CP, vomiting x2, ED presention 4/22. Tx with ibuprofen, colchicine, famotidine, metoprolol. Discharged on colchicine/ibuprofen and metoprolol. Resolution of sx over next few days.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Echocardiogram normal, Electrocardiogram ST segment elevation, Headache
Clinical narrative: fevers, chills, HA, CP, vomiting x2, ED presention 4/22. Tx with ibuprofen, colchicine, famotidine, metoprolol. Discharged on colchicine/ibuprofen and metoprolol. Resolution of sx over next few days.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Troponin increased, Vomiting
Clinical narrative: fevers, chills, HA, CP, vomiting x2, ED presention 4/22. Tx with ibuprofen, colchicine, famotidine, metoprolol. Discharged on colchicine/ibuprofen and metoprolol. Resolution of sx over next few days.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Previously submitted VAERS form for this pt, this is additional information. Hospitalized since May 14, transferred to another HCF 6/9/21.  Pt was positive COVID on admission in hospital, positive COVID on admission to HCF 6/9/21
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy heart, Brain natriuretic peptide increased, C-reactive protein increased, Catheterisation cardiac normal, Chills
Clinical narrative: This patient presented with acute fulminant myocarditis on February 26th, 2021.  His initial symptoms of fever and myalgias started on February 19th.  He then developed HF symptoms with exertional dyspnea, orthopnea and presented to another hospital with cardiogenic shock on February 26th 2021 and transferred to our hospital on February 28th 2021.  He was diagnosed with biopsy confirmed lymphohistiocytic myocarditis.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram abnormal, Haemophagocytic lymphohistiocytosis, Myocarditis, Pyrexia
Clinical narrative: This patient presented with acute fulminant myocarditis on February 26th, 2021.  His initial symptoms of fever and myalgias started on February 19th.  He then developed HF symptoms with exertional dyspnea, orthopnea and presented to another hospital with cardiogenic shock on February 26th 2021 and transferred to our hospital on February 28th 2021.  He was diagnosed with biopsy confirmed lymphohistiocytic myocarditis.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy heart, Blood thyroid stimulating hormone, Cardiogenic shock, Catheterisation cardiac, Dyspnoea exertional
Clinical narrative: This patient presented with acute fulminant myocarditis on February 26th, 2021.  His initial symptoms of fever and myalgias started on February 19th.  He then developed HF symptoms with exertional dyspnea, orthopnea and presented to another hospital with cardiogenic shock on February 26th 2021 and transferred to our hospital on February 28th 2021.  He was diagnosed with biopsy confirmed lymphohistiocytic myocarditis.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, HIV antibody negative, Haemophagocytic lymphohistiocytosis, Immunology test, Myalgia
Clinical narrative: This patient presented with acute fulminant myocarditis on February 26th, 2021.  His initial symptoms of fever and myalgias started on February 19th.  He then developed HF symptoms with exertional dyspnea, orthopnea and presented to another hospital with cardiogenic shock on February 26th 2021 and transferred to our hospital on February 28th 2021.  He was diagnosed with biopsy confirmed lymphohistiocytic myocarditis.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Orthopnoea, Pyrexia, Rheumatoid factor positive, SARS-CoV-2 test negative
Clinical narrative: This patient presented with acute fulminant myocarditis on February 26th, 2021.  His initial symptoms of fever and myalgias started on February 19th.  He then developed HF symptoms with exertional dyspnea, orthopnea and presented to another hospital with cardiogenic shock on February 26th 2021 and transferred to our hospital on February 28th 2021.  He was diagnosed with biopsy confirmed lymphohistiocytic myocarditis.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: This patient presented with acute fulminant myocarditis on February 26th, 2021.  His initial symptoms of fever and myalgias started on February 19th.  He then developed HF symptoms with exertional dyspnea, orthopnea and presented to another hospital with cardiogenic shock on February 26th 2021 and transferred to our hospital on February 28th 2021.  He was diagnosed with biopsy confirmed lymphohistiocytic myocarditis.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bursitis, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: Injection was very high and not centered.  Burning, shooting pain until needle was removed. Felt woozy a few minutes later and was given water and ice for forehead. Felt better after about 45 minutes and went to work.  Sore arm the next day but had heard that was  normal.  Two weeks later arm still hurt with limited mobility so I called the pharmacy that sponsored the clinic for advice.  He said to take Tylenol and call PCP if not better in a week.  Gave it two more weeks and called PCP.  Went to ortho yesterday.  Arm still sore when lifting overhead, undressing and when first waking up.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Injection was very high and not centered.  Burning, shooting pain until needle was removed. Felt woozy a few minutes later and was given water and ice for forehead. Felt better after about 45 minutes and went to work.  Sore arm the next day but had heard that was  normal.  Two weeks later arm still hurt with limited mobility so I called the pharmacy that sponsored the clinic for advice.  He said to take Tylenol and call PCP if not better in a week.  Gave it two more weeks and called PCP.  Went to ortho yesterday.  Arm still sore when lifting overhead, undressing and when first waking up.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Shoulder injury related to vaccine administration, X-ray abnormal
Clinical narrative: Injection was very high and not centered.  Burning, shooting pain until needle was removed. Felt woozy a few minutes later and was given water and ice for forehead. Felt better after about 45 minutes and went to work.  Sore arm the next day but had heard that was  normal.  Two weeks later arm still hurt with limited mobility so I called the pharmacy that sponsored the clinic for advice.  He said to take Tylenol and call PCP if not better in a week.  Gave it two more weeks and called PCP.  Went to ortho yesterday.  Arm still sore when lifting overhead, undressing and when first waking up.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Facial paralysis, Hypoaesthesia oral
Clinical narrative: Eye, cheek, and mouth droopy; Slurred speech; Lip numbness; This is a spontaneous report from a contactable nurse. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 19Feb2021 (at the age of 49 years), as second dose, single dose, for COVID-19 immunization. The patient's medical history included rosacea. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EK9231) on 29Jan2021 (at the age of 49 years) for COVID-19 immunization (intramuscular in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 23Apr2021, the patient experienced lip numbness. On 24Apr2021, the patient experienced eye, cheek, and mouth droopy, and slurred speech. The adverse events resulted in emergency room or department or urgent care. The patient received treatment for the events including steroids and antivirals. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded considering temporal relationship.  This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Back pain, Chest discomfort, Chills, Dyspnoea
Clinical narrative: My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21.  About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep.   On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days.  I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed.   On  5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscle tightness, Musculoskeletal chest pain, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21.  About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep.   On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days.  I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed.   On  5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21.  About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep.   On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days.  I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed.   On  5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Blood immunoglobulin G, Blood immunoglobulin M, Chest X-ray, Chest discomfort
Clinical narrative: My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21.  About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep.   On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days.  I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed.   On  5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram, Cough, Dyspnoea, Fatigue
Clinical narrative: My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21.  About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep.   On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days.  I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed.   On  5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21.  About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep.   On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days.  I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed.   On  5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Blood test, Chest X-ray abnormal, Chest discomfort
Clinical narrative: My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21.  About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep.   On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days.  I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed.   On  5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21.  About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep.   On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days.  I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed.   On  5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Haemoptysis, Pneumonia, Pulmonary embolism
Clinical narrative: My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21.  About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep.   On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days.  I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed.   On  5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.