chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Musculoskeletal chest pain, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced unusual pain in her legs, hips, lower back, pain in both arms, neck  jaw and ribs, decrease in appetite, fever,  and pulmonary embolism.   The patient's medical history was not provided.  Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban.   On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly  for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches.  On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on  07-Feb-2021, she had a temperature of 101.8.  She reported feeling like she had the flu.  Patient reported having a COVID-19 test that came back negative.  The pain continued to increase between Sunday night and Tuesday morning.  Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021.  She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, pain in her legs, hips, lower back, neck, jaw  bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Thyroid hormones increased
Clinical narrative: two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced unusual pain in her legs, hips, lower back, pain in both arms, neck  jaw and ribs, decrease in appetite, fever,  and pulmonary embolism.   The patient's medical history was not provided.  Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban.   On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly  for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches.  On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on  07-Feb-2021, she had a temperature of 101.8.  She reported feeling like she had the flu.  Patient reported having a COVID-19 test that came back negative.  The pain continued to increase between Sunday night and Tuesday morning.  Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021.  She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, pain in her legs, hips, lower back, neck, jaw  bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood creatine phosphokinase, Fall, Rhabdomyolysis, Troponin
Clinical narrative: 78 yo male with HTN, HLD, DM2, CKD (baseline creatinine 1.2), hx of remote CVA (with residual R hand tremor), complete LICA occlusion. Pt recently 2 doses of vaccine (pt does not remember name of vaccine but suspect Pfizer as his 1st dose was 1/28 and 2nd dose 2/25). On 2/26, pt felt weak and fell and was down for hours. EMS called and transported him to ED. Pt left AMA, but subsequently found to have elevated troponin and CK and thus was called to come back to the ED. Pt reports chest pain reproducible with palpation and still has some lower extremity weakness without pain. Admitted for IVF for rhabdo and rule out ACS.   Rhabdo: Suspect related to fall d/t SE from 2nd dose of COVID vaccine. Doubt seizures (pt has baseline R hand tremor). Lower suspicion for ACS. No signs of compartment syndrome. Lower suspicion for statin induced given pt has been on lipitor for years. Improving with IVF.   Elevated trop: Pt with atypical chest pain. Trop peaked at 0.46. No ischemic changes on EKG. Discussed with cardiology, lower suspicion for ACS. Checking TTE. 78 Y male w/hx of L carotid artery occlusion, HLD, HTN, hx of stroke, DM2, CKD3, OA of bilat knees, obesity, multiple pulmonary nodules presenting on 2/20/2021 w/generalized weakness and troponemia. Initially presented on 2/19 to ED with weakness and fall. Found to have CK of 800s and trop of 0.3. Left AMA. Repeat Trop 0.4. Pt called about trop and pt stated continued weakness and thus returned to ED on 2/20. Repeat CK 6000s. Trop peaked at 0.46. Admitted for rhabdomyolysis likely 2/2 being on the floor for 8 hours. Cardiology consulted due to concern for ACS but history inconsistent. Pt started on mIVF on admission. TTE showing EF 55-65% and new mild hypokinesis of mid to apical septum. Cardiology recommending outpatient nuclear myocardial perfusion scan. Evaluated by physical therapy and skilled for home health PT. Prior to discharge CK downtrending (2000s). Seen by social worker and provided information on hiring caregiver given that pt lives alone and has some possible dementia. Econsult for outpatient memory clinic placed to evaluate for underlying dementia. PTA lisinopril-hctz discontinued prior to discharge. PTA statin held given ongoing rhabdo. PTA Asa and atenolol 12.5mg Qhs continued.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute coronary syndrome, Aspartate aminotransferase increased, Asthenia, Blood creatine phosphokinase increased, Blood creatinine increased
Clinical narrative: 78 yo male with HTN, HLD, DM2, CKD (baseline creatinine 1.2), hx of remote CVA (with residual R hand tremor), complete LICA occlusion. Pt recently 2 doses of vaccine (pt does not remember name of vaccine but suspect Pfizer as his 1st dose was 1/28 and 2nd dose 2/25). On 2/26, pt felt weak and fell and was down for hours. EMS called and transported him to ED. Pt left AMA, but subsequently found to have elevated troponin and CK and thus was called to come back to the ED. Pt reports chest pain reproducible with palpation and still has some lower extremity weakness without pain. Admitted for IVF for rhabdo and rule out ACS.   Rhabdo: Suspect related to fall d/t SE from 2nd dose of COVID vaccine. Doubt seizures (pt has baseline R hand tremor). Lower suspicion for ACS. No signs of compartment syndrome. Lower suspicion for statin induced given pt has been on lipitor for years. Improving with IVF.   Elevated trop: Pt with atypical chest pain. Trop peaked at 0.46. No ischemic changes on EKG. Discussed with cardiology, lower suspicion for ACS. Checking TTE. 78 Y male w/hx of L carotid artery occlusion, HLD, HTN, hx of stroke, DM2, CKD3, OA of bilat knees, obesity, multiple pulmonary nodules presenting on 2/20/2021 w/generalized weakness and troponemia. Initially presented on 2/19 to ED with weakness and fall. Found to have CK of 800s and trop of 0.3. Left AMA. Repeat Trop 0.4. Pt called about trop and pt stated continued weakness and thus returned to ED on 2/20. Repeat CK 6000s. Trop peaked at 0.46. Admitted for rhabdomyolysis likely 2/2 being on the floor for 8 hours. Cardiology consulted due to concern for ACS but history inconsistent. Pt started on mIVF on admission. TTE showing EF 55-65% and new mild hypokinesis of mid to apical septum. Cardiology recommending outpatient nuclear myocardial perfusion scan. Evaluated by physical therapy and skilled for home health PT. Prior to discharge CK downtrending (2000s). Seen by social worker and provided information on hiring caregiver given that pt lives alone and has some possible dementia. Econsult for outpatient memory clinic placed to evaluate for underlying dementia. PTA lisinopril-hctz discontinued prior to discharge. PTA statin held given ongoing rhabdo. PTA Asa and atenolol 12.5mg Qhs continued.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, Chest pain, Electrocardiogram normal, Fall, Hypokinesia
Clinical narrative: 78 yo male with HTN, HLD, DM2, CKD (baseline creatinine 1.2), hx of remote CVA (with residual R hand tremor), complete LICA occlusion. Pt recently 2 doses of vaccine (pt does not remember name of vaccine but suspect Pfizer as his 1st dose was 1/28 and 2nd dose 2/25). On 2/26, pt felt weak and fell and was down for hours. EMS called and transported him to ED. Pt left AMA, but subsequently found to have elevated troponin and CK and thus was called to come back to the ED. Pt reports chest pain reproducible with palpation and still has some lower extremity weakness without pain. Admitted for IVF for rhabdo and rule out ACS.   Rhabdo: Suspect related to fall d/t SE from 2nd dose of COVID vaccine. Doubt seizures (pt has baseline R hand tremor). Lower suspicion for ACS. No signs of compartment syndrome. Lower suspicion for statin induced given pt has been on lipitor for years. Improving with IVF.   Elevated trop: Pt with atypical chest pain. Trop peaked at 0.46. No ischemic changes on EKG. Discussed with cardiology, lower suspicion for ACS. Checking TTE. 78 Y male w/hx of L carotid artery occlusion, HLD, HTN, hx of stroke, DM2, CKD3, OA of bilat knees, obesity, multiple pulmonary nodules presenting on 2/20/2021 w/generalized weakness and troponemia. Initially presented on 2/19 to ED with weakness and fall. Found to have CK of 800s and trop of 0.3. Left AMA. Repeat Trop 0.4. Pt called about trop and pt stated continued weakness and thus returned to ED on 2/20. Repeat CK 6000s. Trop peaked at 0.46. Admitted for rhabdomyolysis likely 2/2 being on the floor for 8 hours. Cardiology consulted due to concern for ACS but history inconsistent. Pt started on mIVF on admission. TTE showing EF 55-65% and new mild hypokinesis of mid to apical septum. Cardiology recommending outpatient nuclear myocardial perfusion scan. Evaluated by physical therapy and skilled for home health PT. Prior to discharge CK downtrending (2000s). Seen by social worker and provided information on hiring caregiver given that pt lives alone and has some possible dementia. Econsult for outpatient memory clinic placed to evaluate for underlying dementia. PTA lisinopril-hctz discontinued prior to discharge. PTA statin held given ongoing rhabdo. PTA Asa and atenolol 12.5mg Qhs continued.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Troponin increased
Clinical narrative: 78 yo male with HTN, HLD, DM2, CKD (baseline creatinine 1.2), hx of remote CVA (with residual R hand tremor), complete LICA occlusion. Pt recently 2 doses of vaccine (pt does not remember name of vaccine but suspect Pfizer as his 1st dose was 1/28 and 2nd dose 2/25). On 2/26, pt felt weak and fell and was down for hours. EMS called and transported him to ED. Pt left AMA, but subsequently found to have elevated troponin and CK and thus was called to come back to the ED. Pt reports chest pain reproducible with palpation and still has some lower extremity weakness without pain. Admitted for IVF for rhabdo and rule out ACS.   Rhabdo: Suspect related to fall d/t SE from 2nd dose of COVID vaccine. Doubt seizures (pt has baseline R hand tremor). Lower suspicion for ACS. No signs of compartment syndrome. Lower suspicion for statin induced given pt has been on lipitor for years. Improving with IVF.   Elevated trop: Pt with atypical chest pain. Trop peaked at 0.46. No ischemic changes on EKG. Discussed with cardiology, lower suspicion for ACS. Checking TTE. 78 Y male w/hx of L carotid artery occlusion, HLD, HTN, hx of stroke, DM2, CKD3, OA of bilat knees, obesity, multiple pulmonary nodules presenting on 2/20/2021 w/generalized weakness and troponemia. Initially presented on 2/19 to ED with weakness and fall. Found to have CK of 800s and trop of 0.3. Left AMA. Repeat Trop 0.4. Pt called about trop and pt stated continued weakness and thus returned to ED on 2/20. Repeat CK 6000s. Trop peaked at 0.46. Admitted for rhabdomyolysis likely 2/2 being on the floor for 8 hours. Cardiology consulted due to concern for ACS but history inconsistent. Pt started on mIVF on admission. TTE showing EF 55-65% and new mild hypokinesis of mid to apical septum. Cardiology recommending outpatient nuclear myocardial perfusion scan. Evaluated by physical therapy and skilled for home health PT. Prior to discharge CK downtrending (2000s). Seen by social worker and provided information on hiring caregiver given that pt lives alone and has some possible dementia. Econsult for outpatient memory clinic placed to evaluate for underlying dementia. PTA lisinopril-hctz discontinued prior to discharge. PTA statin held given ongoing rhabdo. PTA Asa and atenolol 12.5mg Qhs continued.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial discomfort, Paraesthesia oral, Rash
Clinical narrative: Several hours after receiving dose 1 of the Moderna Covid vaccine the patient states that she experienced a red rash on her face and tingling in her lips. She called her doctor and was instructed to take Benadryl, the rash and tingling resolved on its own with Benadryl and no further intervention was needed per the patient. The doctor instructed the patient to continue the vaccine series and get the second dose when due.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Rash, Rash erythematous
Clinical narrative: Several hours after receiving dose 1 of the Moderna Covid vaccine the patient states that she experienced a red rash on her face and tingling in her lips. She called her doctor and was instructed to take Benadryl, the rash and tingling resolved on its own with Benadryl and no further intervention was needed per the patient. The doctor instructed the patient to continue the vaccine series and get the second dose when due.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pyrexia, Syncope
Clinical narrative: one episode syncope with fall; one episode syncope with fall; fever 100-101.5, 24+ hoursat noon 2-28; dizziness; nausea 2-3; extreme lassitude 24 hours; first dose on 16Jan2021/second dose on 27Feb2021 (43 days); first dose on 16Jan2021/second dose on 27Feb2021 (43 days); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EM9810), via an unspecified route of administration in arm left on 27Feb2021 10:15 (at the age of 65years) as single dose for covid-19 immunisation. The patient received her first dose of bnt162b2 on 16Jan2021 on left arm at 13:30, Lot: EL3249 as single dose for COVID-19 immunization. Medical history included allergies to penicillin, sulfa, pollen, mold, gluten and nightshades and covid (prior vaccination). Concomitant medications included ascorbic acid (VIT C); ergocalciferol (VIT D); fish oil; ubidecarenone (COQ10); policosanol and unspecified multivitamin; all in two weeks. The patient experienced fever 100-101.5, 24+ hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours on 27Feb2021 at 23:45. There was no treatment for the events. The patient was not Covid tested post vaccination. No other vaccine in four weeks. The outcome of the events syncope, fall, pyrexia, dizziness, nausea and fatigue was recovered on an unspecified date in 2021.; Sender's Comments: Based on the information provided, this patient with a medical history of allergies to penicillin, sulfa, pollen, mold, gluten and nightshades and covid (prior vaccination) experienced fever, dizziness, nausea,  one episode syncope with fall, no injury  and extreme lassitude after receiving second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Given the plausible close temporal association, a contribution of suspect product to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dizziness, Fall, Fatigue, Inappropriate schedule of product administration
Clinical narrative: one episode syncope with fall; one episode syncope with fall; fever 100-101.5, 24+ hoursat noon 2-28; dizziness; nausea 2-3; extreme lassitude 24 hours; first dose on 16Jan2021/second dose on 27Feb2021 (43 days); first dose on 16Jan2021/second dose on 27Feb2021 (43 days); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EM9810), via an unspecified route of administration in arm left on 27Feb2021 10:15 (at the age of 65years) as single dose for covid-19 immunisation. The patient received her first dose of bnt162b2 on 16Jan2021 on left arm at 13:30, Lot: EL3249 as single dose for COVID-19 immunization. Medical history included allergies to penicillin, sulfa, pollen, mold, gluten and nightshades and covid (prior vaccination). Concomitant medications included ascorbic acid (VIT C); ergocalciferol (VIT D); fish oil; ubidecarenone (COQ10); policosanol and unspecified multivitamin; all in two weeks. The patient experienced fever 100-101.5, 24+ hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours on 27Feb2021 at 23:45. There was no treatment for the events. The patient was not Covid tested post vaccination. No other vaccine in four weeks. The outcome of the events syncope, fall, pyrexia, dizziness, nausea and fatigue was recovered on an unspecified date in 2021.; Sender's Comments: Based on the information provided, this patient with a medical history of allergies to penicillin, sulfa, pollen, mold, gluten and nightshades and covid (prior vaccination) experienced fever, dizziness, nausea,  one episode syncope with fall, no injury  and extreme lassitude after receiving second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Given the plausible close temporal association, a contribution of suspect product to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Off label use, Pyrexia, Syncope
Clinical narrative: one episode syncope with fall; one episode syncope with fall; fever 100-101.5, 24+ hoursat noon 2-28; dizziness; nausea 2-3; extreme lassitude 24 hours; first dose on 16Jan2021/second dose on 27Feb2021 (43 days); first dose on 16Jan2021/second dose on 27Feb2021 (43 days); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EM9810), via an unspecified route of administration in arm left on 27Feb2021 10:15 (at the age of 65years) as single dose for covid-19 immunisation. The patient received her first dose of bnt162b2 on 16Jan2021 on left arm at 13:30, Lot: EL3249 as single dose for COVID-19 immunization. Medical history included allergies to penicillin, sulfa, pollen, mold, gluten and nightshades and covid (prior vaccination). Concomitant medications included ascorbic acid (VIT C); ergocalciferol (VIT D); fish oil; ubidecarenone (COQ10); policosanol and unspecified multivitamin; all in two weeks. The patient experienced fever 100-101.5, 24+ hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours on 27Feb2021 at 23:45. There was no treatment for the events. The patient was not Covid tested post vaccination. No other vaccine in four weeks. The outcome of the events syncope, fall, pyrexia, dizziness, nausea and fatigue was recovered on an unspecified date in 2021.; Sender's Comments: Based on the information provided, this patient with a medical history of allergies to penicillin, sulfa, pollen, mold, gluten and nightshades and covid (prior vaccination) experienced fever, dizziness, nausea,  one episode syncope with fall, no injury  and extreme lassitude after receiving second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Given the plausible close temporal association, a contribution of suspect product to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Peripheral swelling
Clinical narrative: My face went numb; Headache; This is a spontaneous report from a contactable consumer.  A 67-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, in the left arm, on16Feb2021 at 10:15 (at the age of 67 years-old) as a single dose for covid-19 immunisation.  Medical history included headache, anaphylaxis reactions to food allergies, Spinich, cabbage, sulfa based drugs diabetes, and asthma. The patient had not received any other vaccinations within 4 weeks and was not diagnosed with COVID-19. Concomitant medication included diabetes meds and  insulin glargine (BASAGLAR).  The patient reported on 16Feb2021, at 10:45 after waiting 30 as instructed, I had a reaction 5 - 10 minutes later. My face went numb, and then a headache started. I have had only 1headache in my life prior to this. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the event was recovered
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: My face went numb; Headache; This is a spontaneous report from a contactable consumer.  A 67-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, in the left arm, on16Feb2021 at 10:15 (at the age of 67 years-old) as a single dose for covid-19 immunisation.  Medical history included headache, anaphylaxis reactions to food allergies, Spinich, cabbage, sulfa based drugs diabetes, and asthma. The patient had not received any other vaccinations within 4 weeks and was not diagnosed with COVID-19. Concomitant medication included diabetes meds and  insulin glargine (BASAGLAR).  The patient reported on 16Feb2021, at 10:45 after waiting 30 as instructed, I had a reaction 5 - 10 minutes later. My face went numb, and then a headache started. I have had only 1headache in my life prior to this. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the event was recovered
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Constipation, Flatulence, Headache
Clinical narrative: Bloating; Constipation; Gas; Headache; This is a spontaneous report from a contactable consumer reporting for himself and his wife. This consumer reported similar events for two patients. This is the second of two reports.   A 66-year-old female patient (reporter's wife) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982), intramuscular on 26Jan2021 at a single dose on the right arm for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. The patient did not have prior vaccinations within 4 weeks of the COVID vaccine. The reporter called for himself and his wife. He reported that they looked at the at the symptoms on the vaccine fact sheet and they did not have any of those symptoms. They received the first dose of the vaccine on 26Jan2021. The first couple of days they had a little bit of a headache starting on 27Jan2021. The third day, 29Jan2021, they started having constipation and bloating which is not normal for them. They are having a lot of gas and are very bloated. The reporter and patient was asking if anyone else has reported this since it is unusual for them. The patient then stated that she had just a very mild headache. She has been able to go to the bathroom a little bit. Usually she is going to the bathroom a lot. The patient stated that the gas and bloating is unreal. All she had last night was chicken broth and a piece of toast for dinner. She took Tylenol for the headache. She is not taking anything for constipation. She is drinking caffeinated coffee which she never drinks or she would be going to the bathroom all day. She just wishes she could fart. The outcome of headache was recovered on 29Jan2021. The outcome of bloating, constipation and gas was not recovered.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling at injection site and swelling of hands. Next day migraine, vertigo and rash on right leg. The vertigo has consisted and the rash has spread throughout my whole right leg and now on my left leg.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Injection site swelling, Migraine, Peripheral swelling, Rash
Clinical narrative: Swelling at injection site and swelling of hands. Next day migraine, vertigo and rash on right leg. The vertigo has consisted and the rash has spread throughout my whole right leg and now on my left leg.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Swelling at injection site and swelling of hands. Next day migraine, vertigo and rash on right leg. The vertigo has consisted and the rash has spread throughout my whole right leg and now on my left leg.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria, Echocardiogram
Clinical narrative: stroke; fell; body was pulling to one side, he fell and hit his head on the couch; body was pulling to one side, he fell and hit his head on the couch; slurred speech; numbness in arm/left arm was numb; not able to walk/he could not really walk on his own.; facial drooping on the left side and his whole left side is not working; facial drooping on the left side and his whole left side is not working; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm), on 28Feb2021, 12:00 at single dose for COVID-19 immunisation.  Medical history included High blood pressure and High cholesterol. The patient had no known allergies. Ongoing concomitant medications included atorvastatin for high cholesterol and atenolol for blood pressure. It was reported that the patient received the 1st vaccine on Sunday afternoon, then Monday morning, 01Mar2021, 08:30, he collapsed and had a stroke and they had to call an ambulance. The reporter stated that his body was pulling to one side, he fell and hit his head on the couch, and his speech was slurred, and his left arm was numb. When they tried to get him up, he could not really walk on his own. She said that he developed facial drooping on the left side and his whole left side was not working. He had his physical last week, on an unspecified date and everything was good at that time. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient was hospitalized on an unspecified date for 3 days due to the events. Patient was currently in the hospital. The patient received unspecified treatment for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fall, Gait disturbance, Hypoaesthesia, Magnetic resonance imaging, Posture abnormal
Clinical narrative: stroke; fell; body was pulling to one side, he fell and hit his head on the couch; body was pulling to one side, he fell and hit his head on the couch; slurred speech; numbness in arm/left arm was numb; not able to walk/he could not really walk on his own.; facial drooping on the left side and his whole left side is not working; facial drooping on the left side and his whole left side is not working; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm), on 28Feb2021, 12:00 at single dose for COVID-19 immunisation.  Medical history included High blood pressure and High cholesterol. The patient had no known allergies. Ongoing concomitant medications included atorvastatin for high cholesterol and atenolol for blood pressure. It was reported that the patient received the 1st vaccine on Sunday afternoon, then Monday morning, 01Mar2021, 08:30, he collapsed and had a stroke and they had to call an ambulance. The reporter stated that his body was pulling to one side, he fell and hit his head on the couch, and his speech was slurred, and his left arm was numb. When they tried to get him up, he could not really walk on his own. She said that he developed facial drooping on the left side and his whole left side was not working. He had his physical last week, on an unspecified date and everything was good at that time. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient was hospitalized on an unspecified date for 3 days due to the events. Patient was currently in the hospital. The patient received unspecified treatment for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: stroke; fell; body was pulling to one side, he fell and hit his head on the couch; body was pulling to one side, he fell and hit his head on the couch; slurred speech; numbness in arm/left arm was numb; not able to walk/he could not really walk on his own.; facial drooping on the left side and his whole left side is not working; facial drooping on the left side and his whole left side is not working; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm), on 28Feb2021, 12:00 at single dose for COVID-19 immunisation.  Medical history included High blood pressure and High cholesterol. The patient had no known allergies. Ongoing concomitant medications included atorvastatin for high cholesterol and atenolol for blood pressure. It was reported that the patient received the 1st vaccine on Sunday afternoon, then Monday morning, 01Mar2021, 08:30, he collapsed and had a stroke and they had to call an ambulance. The reporter stated that his body was pulling to one side, he fell and hit his head on the couch, and his speech was slurred, and his left arm was numb. When they tried to get him up, he could not really walk on his own. She said that he developed facial drooping on the left side and his whole left side was not working. He had his physical last week, on an unspecified date and everything was good at that time. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient was hospitalized on an unspecified date for 3 days due to the events. Patient was currently in the hospital. The patient received unspecified treatment for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Cerebrovascular accident, Dysarthria, Facial paralysis, Fall
Clinical narrative: stroke; fell; body was pulling to one side, he fell and hit his head on the couch; body was pulling to one side, he fell and hit his head on the couch; slurred speech; numbness in arm/left arm was numb; not able to walk/he could not really walk on his own.; facial drooping on the left side and his whole left side is not working; facial drooping on the left side and his whole left side is not working; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm), on 28Feb2021, 12:00 at single dose for COVID-19 immunisation.  Medical history included High blood pressure and High cholesterol. The patient had no known allergies. Ongoing concomitant medications included atorvastatin for high cholesterol and atenolol for blood pressure. It was reported that the patient received the 1st vaccine on Sunday afternoon, then Monday morning, 01Mar2021, 08:30, he collapsed and had a stroke and they had to call an ambulance. The reporter stated that his body was pulling to one side, he fell and hit his head on the couch, and his speech was slurred, and his left arm was numb. When they tried to get him up, he could not really walk on his own. She said that he developed facial drooping on the left side and his whole left side was not working. He had his physical last week, on an unspecified date and everything was good at that time. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient was hospitalized on an unspecified date for 3 days due to the events. Patient was currently in the hospital. The patient received unspecified treatment for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait inability, Head injury, Hemiplegia, Hypoaesthesia, Physical examination
Clinical narrative: stroke; fell; body was pulling to one side, he fell and hit his head on the couch; body was pulling to one side, he fell and hit his head on the couch; slurred speech; numbness in arm/left arm was numb; not able to walk/he could not really walk on his own.; facial drooping on the left side and his whole left side is not working; facial drooping on the left side and his whole left side is not working; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm), on 28Feb2021, 12:00 at single dose for COVID-19 immunisation.  Medical history included High blood pressure and High cholesterol. The patient had no known allergies. Ongoing concomitant medications included atorvastatin for high cholesterol and atenolol for blood pressure. It was reported that the patient received the 1st vaccine on Sunday afternoon, then Monday morning, 01Mar2021, 08:30, he collapsed and had a stroke and they had to call an ambulance. The reporter stated that his body was pulling to one side, he fell and hit his head on the couch, and his speech was slurred, and his left arm was numb. When they tried to get him up, he could not really walk on his own. She said that he developed facial drooping on the left side and his whole left side was not working. He had his physical last week, on an unspecified date and everything was good at that time. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient was hospitalized on an unspecified date for 3 days due to the events. Patient was currently in the hospital. The patient received unspecified treatment for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Lack of spontaneous speech
Clinical narrative: stroke; fell; body was pulling to one side, he fell and hit his head on the couch; body was pulling to one side, he fell and hit his head on the couch; slurred speech; numbness in arm/left arm was numb; not able to walk/he could not really walk on his own.; facial drooping on the left side and his whole left side is not working; facial drooping on the left side and his whole left side is not working; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm), on 28Feb2021, 12:00 at single dose for COVID-19 immunisation.  Medical history included High blood pressure and High cholesterol. The patient had no known allergies. Ongoing concomitant medications included atorvastatin for high cholesterol and atenolol for blood pressure. It was reported that the patient received the 1st vaccine on Sunday afternoon, then Monday morning, 01Mar2021, 08:30, he collapsed and had a stroke and they had to call an ambulance. The reporter stated that his body was pulling to one side, he fell and hit his head on the couch, and his speech was slurred, and his left arm was numb. When they tried to get him up, he could not really walk on his own. She said that he developed facial drooping on the left side and his whole left side was not working. He had his physical last week, on an unspecified date and everything was good at that time. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient was hospitalized on an unspecified date for 3 days due to the events. Patient was currently in the hospital. The patient received unspecified treatment for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: A few minutes after the vaccine my heart began palpatating and I began sweating profusely.  My vitals were checked, I was given water and moved to a cooler area of the facility.  HR was still elevated but I wasnt feeling as flushed.  By 4pm that evening I began having having chills and a fever of 100-100.4 which lasted about 4hrs.  Later that evening my HR elevated to 125 with the feeling of feeling I was having a heart attack.  By that Wed. my HR was still at 125 in motion and about 75 still so I went to visit my PCP on Thurs and when I arrived the HR was 77 but during the visit it elevated to 125 and blood work was done resulting in my tyroid level elevated and since getting the vaccine my HR had been up and down.  When in motion its elevated and when sitting its around 75.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Flushing, Heart rate increased, Hyperhidrosis, Myocardial infarction
Clinical narrative: A few minutes after the vaccine my heart began palpatating and I began sweating profusely.  My vitals were checked, I was given water and moved to a cooler area of the facility.  HR was still elevated but I wasnt feeling as flushed.  By 4pm that evening I began having having chills and a fever of 100-100.4 which lasted about 4hrs.  Later that evening my HR elevated to 125 with the feeling of feeling I was having a heart attack.  By that Wed. my HR was still at 125 in motion and about 75 still so I went to visit my PCP on Thurs and when I arrived the HR was 77 but during the visit it elevated to 125 and blood work was done resulting in my tyroid level elevated and since getting the vaccine my HR had been up and down.  When in motion its elevated and when sitting its around 75.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Thyroid function test abnormal
Clinical narrative: A few minutes after the vaccine my heart began palpatating and I began sweating profusely.  My vitals were checked, I was given water and moved to a cooler area of the facility.  HR was still elevated but I wasnt feeling as flushed.  By 4pm that evening I began having having chills and a fever of 100-100.4 which lasted about 4hrs.  Later that evening my HR elevated to 125 with the feeling of feeling I was having a heart attack.  By that Wed. my HR was still at 125 in motion and about 75 still so I went to visit my PCP on Thurs and when I arrived the HR was 77 but during the visit it elevated to 125 and blood work was done resulting in my tyroid level elevated and since getting the vaccine my HR had been up and down.  When in motion its elevated and when sitting its around 75.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature decreased, Dizziness
Clinical narrative: A few minutes after the vaccine my heart began palpatating and I began sweating profusely.  My vitals were checked, I was given water and moved to a cooler area of the facility.  HR was still elevated but I wasnt feeling as flushed.  By 4pm that evening I began having having chills and a fever of 100-100.4 which lasted about 4hrs.  Later that evening my HR elevated to 125 with the feeling of feeling I was having a heart attack.  By that Wed. my HR was still at 125 in motion and about 75 still so I went to visit my PCP on Thurs and when I arrived the HR was 77 but during the visit it elevated to 125 and blood work was done resulting in my tyroid level elevated and since getting the vaccine my HR had been up and down.  When in motion its elevated and when sitting its around 75.
Age: 75.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Injection site swelling, Myalgia, Nausea, Rash
Clinical narrative: Swelling at injection site, headache, nauseated, rash, muscle pain, sweating, tiredness
Age: 75.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site swelling, Myalgia
Clinical narrative: Swelling at injection site, headache, nauseated, rash, muscle pain, sweating, tiredness
Age: 75.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Rash
Clinical narrative: Swelling at injection site, headache, nauseated, rash, muscle pain, sweating, tiredness
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bursitis, Mobility decreased, Pain in extremity
Clinical narrative: Patient reports she is a medical assistant, and that vaccine given to close to the AC joint.  Patient now has bursitis.  Significant pain in shoulder and arm.  would like another dose of vaccine.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthropathy, Bursitis, Pain in extremity
Clinical narrative: Patient reports she is a medical assistant, and that vaccine given to close to the AC joint.  Patient now has bursitis.  Significant pain in shoulder and arm.  would like another dose of vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram, Feeling abnormal
Clinical narrative: Tongue swelling, throat swelling, shaking, trouble breathing, leg numbness, troublesome.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Immediate post-injection reaction, Neuralgia, Pharyngeal swelling
Clinical narrative: Tongue swelling, throat swelling, shaking, trouble breathing, leg numbness, troublesome.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling, throat swelling, shaking, trouble breathing, leg numbness, troublesome.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood gases, Computerised tomogram, Dyspnoea, Electrocardiogram, Hypoaesthesia
Clinical narrative: Tongue swelling, throat swelling, shaking, trouble breathing, leg numbness, troublesome.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pulmonary function test, Swollen tongue, Tremor
Clinical narrative: Tongue swelling, throat swelling, shaking, trouble breathing, leg numbness, troublesome.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: itching 5 min after the injection, then developed a rash that has been coming and going daily, Benadryl has helped  she is still itchy daily and is having intermittent rash now 6 days later though every day is better