chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
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
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lip oedema, Muscle contractions involuntary, Pruritus
Clinical narrative: 45 minutes after injection slight lip swelling and swelling in left cheek hei 's and years took 20 Tech and histamine and symptoms subsided in a few hours.  *Important, 30 hours after injection the following night at 11:00 p.m. began to experience pronounced generalized Fasciculations -  Similar to those I experienced After receiving the 3rd of 5 doses of the rabies vaccine in 2008. Strong , generalized muscular Fasciculations are now persisting 7 weeks after receiving the 1st dose of the Pfizer Covid vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergy test negative, Injection site reaction, Lip swelling, Muscle contractions involuntary, Swelling face
Clinical narrative: 45 minutes after injection slight lip swelling and swelling in left cheek hei 's and years took 20 Tech and histamine and symptoms subsided in a few hours.  *Important, 30 hours after injection the following night at 11:00 p.m. began to experience pronounced generalized Fasciculations -  Similar to those I experienced After receiving the 3rd of 5 doses of the rabies vaccine in 2008. Strong , generalized muscular Fasciculations are now persisting 7 weeks after receiving the 1st dose of the Pfizer Covid vaccine.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Aphonia, Death, Dyspnoea, Pain in extremity, Respiratory tract congestion
Clinical narrative: 2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with "pneumonia" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Rhinorrhoea
Clinical narrative: 2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with "pneumonia" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Aphonia, Breath sounds abnormal, Chills, Death, Dry throat
Clinical narrative: 2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with "pneumonia" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Dyspnoea, Eye movement disorder, Fatigue, Immobile, Nasopharyngitis
Clinical narrative: 2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with "pneumonia" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pain in extremity, Pallor, Pneumonia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: 2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with "pneumonia" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Tremor
Clinical narrative: 2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with "pneumonia" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Headache, Loss of personal independence in daily activities, Magnetic resonance imaging, Mental impairment
Clinical narrative: Headache; Nausea; This is a spontaneous report from a contactable physician (patient). A 53-year-old female patient received BNT162B2 (lot number: EL9261, expiration date: May2021) second dose on 31Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. The patient previously took BNT162B2 (lot number: EL3246, expiration date: Apr2021) first dose on 11Jan2021 (age at vaccination was 53-year-old) at single dose for covid-19 immunisation. She was wondering if anyone else has reported side effects of headaches and nausea 2.5 weeks after getting the vaccine, the second shot. She is wondering if anyone else is reporting having it for that long. She has to get an MRI and all sorts of other testing but she is hoping that its from the vaccine. The second dose was 31Jan2021 and the headaches started 01Feb2021, it is more like pressure in her head and nausea. She wakes up with it. The nausea persisted about the same the whole time. The outcome of the events was not recovered. The seriousness criteria was reported as medically significant. Reaction assessed: Headache, Source of assessment: Primary Source Reporter  , Method of assessment: Global Introspection, Drug result: Related; Reaction assessed: Nausea, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event headache and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neuropathy peripheral, Paraesthesia
Clinical narrative: Headache; Nausea; This is a spontaneous report from a contactable physician (patient). A 53-year-old female patient received BNT162B2 (lot number: EL9261, expiration date: May2021) second dose on 31Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. The patient previously took BNT162B2 (lot number: EL3246, expiration date: Apr2021) first dose on 11Jan2021 (age at vaccination was 53-year-old) at single dose for covid-19 immunisation. She was wondering if anyone else has reported side effects of headaches and nausea 2.5 weeks after getting the vaccine, the second shot. She is wondering if anyone else is reporting having it for that long. She has to get an MRI and all sorts of other testing but she is hoping that its from the vaccine. The second dose was 31Jan2021 and the headaches started 01Feb2021, it is more like pressure in her head and nausea. She wakes up with it. The nausea persisted about the same the whole time. The outcome of the events was not recovered. The seriousness criteria was reported as medically significant. Reaction assessed: Headache, Source of assessment: Primary Source Reporter  , Method of assessment: Global Introspection, Drug result: Related; Reaction assessed: Nausea, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event headache and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This is a spontaneous report from a contactable physician (patient). A 53-year-old female patient received BNT162B2 (lot number: EL9261, expiration date: May2021) second dose on 31Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. The patient previously took BNT162B2 (lot number: EL3246, expiration date: Apr2021) first dose on 11Jan2021 (age at vaccination was 53-year-old) at single dose for covid-19 immunisation. She was wondering if anyone else has reported side effects of headaches and nausea 2.5 weeks after getting the vaccine, the second shot. She is wondering if anyone else is reporting having it for that long. She has to get an MRI and all sorts of other testing but she is hoping that its from the vaccine. The second dose was 31Jan2021 and the headaches started 01Feb2021, it is more like pressure in her head and nausea. She wakes up with it. The nausea persisted about the same the whole time. The outcome of the events was not recovered. The seriousness criteria was reported as medically significant. Reaction assessed: Headache, Source of assessment: Primary Source Reporter  , Method of assessment: Global Introspection, Drug result: Related; Reaction assessed: Nausea, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event headache and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Patient received Janssen Covid-19 vaccine at a clinic on 3/13/21. Night after receiving shot, patient complained of headache and felt ill. Patient went to sleep and woke up around 1am the next morning with severe chills and fever. Patient developed seizures at 4am and went into cardiac arrest minutes later. 911 arrived and attempted to revive patient. Patient was declared dead at 605am on Sunday morning 3/14/21.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Chills, Death, Headache, Malaise
Clinical narrative: Patient received Janssen Covid-19 vaccine at a clinic on 3/13/21. Night after receiving shot, patient complained of headache and felt ill. Patient went to sleep and woke up around 1am the next morning with severe chills and fever. Patient developed seizures at 4am and went into cardiac arrest minutes later. 911 arrived and attempted to revive patient. Patient was declared dead at 605am on Sunday morning 3/14/21.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient received Janssen Covid-19 vaccine at a clinic on 3/13/21. Night after receiving shot, patient complained of headache and felt ill. Patient went to sleep and woke up around 1am the next morning with severe chills and fever. Patient developed seizures at 4am and went into cardiac arrest minutes later. 911 arrived and attempted to revive patient. Patient was declared dead at 605am on Sunday morning 3/14/21.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Cardiac failure, Chills, Headache, Malaise
Clinical narrative: Patient received Janssen Covid-19 vaccine at a clinic on 3/13/21. Night after receiving shot, patient complained of headache and felt ill. Patient went to sleep and woke up around 1am the next morning with severe chills and fever. Patient developed seizures at 4am and went into cardiac arrest minutes later. 911 arrived and attempted to revive patient. Patient was declared dead at 605am on Sunday morning 3/14/21.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: Patient received Janssen Covid-19 vaccine at a clinic on 3/13/21. Night after receiving shot, patient complained of headache and felt ill. Patient went to sleep and woke up around 1am the next morning with severe chills and fever. Patient developed seizures at 4am and went into cardiac arrest minutes later. 911 arrived and attempted to revive patient. Patient was declared dead at 605am on Sunday morning 3/14/21.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash on left arm 8 days after vaccine. Minor rash, started as "couple of little dots"  and spread to oval/rectangle; gone after a couple of days. Rash can no longer be seen and is either completely resolved or possibly very slightly itchy. Patient also submitted a VAERS report herself. She had a local reaction (redness, swelling, irritation) to a flu shot several years ago but gets the flu shot every year and has not had other reactions.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on left arm 8 days after vaccine. Minor rash, started as "couple of little dots"  and spread to oval/rectangle; gone after a couple of days. Rash can no longer be seen and is either completely resolved or possibly very slightly itchy. Patient also submitted a VAERS report herself. She had a local reaction (redness, swelling, irritation) to a flu shot several years ago but gets the flu shot every year and has not had other reactions.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Laboratory test, Syncope
Clinical narrative: syncopal episode x 8 seconds  4 minutes after vaccine received
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: syncopal episode x 8 seconds  4 minutes after vaccine received
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: "throat Tightness"
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: "throat Tightness"
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching
Clinical narrative: March 13 was vaccinated at 2 PM and 12 hours later she began to feel twitching/shaking in all extremities associated with difficulty walking due to the "jerking twitching"..
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Movement disorder, Muscle twitching, Tremor
Clinical narrative: March 13 was vaccinated at 2 PM and 12 hours later she began to feel twitching/shaking in all extremities associated with difficulty walking due to the "jerking twitching"..
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dysphagia, Ear discomfort, Headache, Lip swelling
Clinical narrative: Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, stayed for observation for about 20min and was feeling better so left - but about halfway home lips started to swell, tongue started to feel thick and throat started hurting - ate a popsicle which seemed to help. Then that evening took her usual dose of lisinopril and about an hour later noticed tightness developing in her neck and new headache, followed by swelling of lips and tongue.  Took tylenol arthritis which she usually takes for her neck problems, and went to bed, but a couple of hours later developed burning in her ears and jaw, headache persisted, and swelling seemed to have gone down with ice chips.  Lisinopril d/c'd  on 3/14, converted 3/17 to losartan which she started at 5pm and within 2 hours had recurrent angioedema for which she was told to call emergency responders, used EpiPen, discharged from ED after 4 hours with another change in BP medication and Medrol dosepak.   Allergist recommends no further COVID vaccines.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Musculoskeletal stiffness, Swelling face, Swollen tongue
Clinical narrative: Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, stayed for observation for about 20min and was feeling better so left - but about halfway home lips started to swell, tongue started to feel thick and throat started hurting - ate a popsicle which seemed to help. Then that evening took her usual dose of lisinopril and about an hour later noticed tightness developing in her neck and new headache, followed by swelling of lips and tongue.  Took tylenol arthritis which she usually takes for her neck problems, and went to bed, but a couple of hours later developed burning in her ears and jaw, headache persisted, and swelling seemed to have gone down with ice chips.  Lisinopril d/c'd  on 3/14, converted 3/17 to losartan which she started at 5pm and within 2 hours had recurrent angioedema for which she was told to call emergency responders, used EpiPen, discharged from ED after 4 hours with another change in BP medication and Medrol dosepak.   Allergist recommends no further COVID vaccines.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Ear discomfort, Headache, Lip swelling, Muscle tightness
Clinical narrative: Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, stayed for observation for about 20min and was feeling better so left - but about halfway home lips started to swell, tongue started to feel thick and throat started hurting - ate a popsicle which seemed to help. Then that evening took her usual dose of lisinopril and about an hour later noticed tightness developing in her neck and new headache, followed by swelling of lips and tongue.  Took tylenol arthritis which she usually takes for her neck problems, and went to bed, but a couple of hours later developed burning in her ears and jaw, headache persisted, and swelling seemed to have gone down with ice chips.  Lisinopril d/c'd  on 3/14, converted 3/17 to losartan which she started at 5pm and within 2 hours had recurrent angioedema for which she was told to call emergency responders, used EpiPen, discharged from ED after 4 hours with another change in BP medication and Medrol dosepak.   Allergist recommends no further COVID vaccines.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Skin burning sensation, Skin tightness, Swollen tongue, Tongue disorder
Clinical narrative: Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, stayed for observation for about 20min and was feeling better so left - but about halfway home lips started to swell, tongue started to feel thick and throat started hurting - ate a popsicle which seemed to help. Then that evening took her usual dose of lisinopril and about an hour later noticed tightness developing in her neck and new headache, followed by swelling of lips and tongue.  Took tylenol arthritis which she usually takes for her neck problems, and went to bed, but a couple of hours later developed burning in her ears and jaw, headache persisted, and swelling seemed to have gone down with ice chips.  Lisinopril d/c'd  on 3/14, converted 3/17 to losartan which she started at 5pm and within 2 hours had recurrent angioedema for which she was told to call emergency responders, used EpiPen, discharged from ED after 4 hours with another change in BP medication and Medrol dosepak.   Allergist recommends no further COVID vaccines.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test positive, Tenderness
Clinical narrative: He just tested positive to covid on Wednesday; He just tested positive to covid on Wednesday; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The caller mentioned that he received the first dose of the COVID 19 vaccine on 01Feb2021 and was scheduled to get the second dose on 03Mar2021, more than a month away from the first. He said that he just tested positive to COVID on Wednesday (the date not specified), so he wanted to know in what position he was. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He just tested positive to covid on Wednesday; He just tested positive to covid on Wednesday; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The caller mentioned that he received the first dose of the COVID 19 vaccine on 01Feb2021 and was scheduled to get the second dose on 03Mar2021, more than a month away from the first. He said that he just tested positive to COVID on Wednesday (the date not specified), so he wanted to know in what position he was. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: The initial injection was given too high and I had immediate excruciating pain and screamed out and became nauseated and faint.  The man giving the shot, took the needle out without ever injecting the vaccine.  A paramedic came over and said that the shot had been given way too high and that a nerve was hit.  I continue to have pain in my lower arm and hand.  They did give me the vaccine in my right arm and it was totally fine with no pain but my left arm is in pain.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain, Nausea, Pain in extremity
Clinical narrative: The initial injection was given too high and I had immediate excruciating pain and screamed out and became nauseated and faint.  The man giving the shot, took the needle out without ever injecting the vaccine.  A paramedic came over and said that the shot had been given way too high and that a nerve was hit.  I continue to have pain in my lower arm and hand.  They did give me the vaccine in my right arm and it was totally fine with no pain but my left arm is in pain.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: fever 3 days after vaccine, daily fevers since
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal X-ray, Blood test, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram thorax
Clinical narrative: Encephalopathy concerning for postictal state Secondary Discharge Diagnoses Potential ventricular arrhythmia Community-acquired pneumonia History of atrial fibrillation Aortic stenosis status post TAVR Nonobstructive CAD Chronic G1 diastolic dysfunction without acute decompensation
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electroencephalogram, Intensive care, Magnetic resonance imaging head
Clinical narrative: Encephalopathy concerning for postictal state Secondary Discharge Diagnoses Potential ventricular arrhythmia Community-acquired pneumonia History of atrial fibrillation Aortic stenosis status post TAVR Nonobstructive CAD Chronic G1 diastolic dysfunction without acute decompensation
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Encephalopathy concerning for postictal state Secondary Discharge Diagnoses Potential ventricular arrhythmia Community-acquired pneumonia History of atrial fibrillation Aortic stenosis status post TAVR Nonobstructive CAD Chronic G1 diastolic dysfunction without acute decompensation
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram abdomen, Diastolic dysfunction, Echocardiogram
Clinical narrative: Encephalopathy concerning for postictal state Secondary Discharge Diagnoses Potential ventricular arrhythmia Community-acquired pneumonia History of atrial fibrillation Aortic stenosis status post TAVR Nonobstructive CAD Chronic G1 diastolic dysfunction without acute decompensation
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electroencephalogram, Encephalopathy, Magnetic resonance imaging, Pneumonia
Clinical narrative: Encephalopathy concerning for postictal state Secondary Discharge Diagnoses Potential ventricular arrhythmia Community-acquired pneumonia History of atrial fibrillation Aortic stenosis status post TAVR Nonobstructive CAD Chronic G1 diastolic dysfunction without acute decompensation
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Thrombosis
Clinical narrative: pulmonary embolism Narrative:  Patient received first COVID-19 vaccine (Pfizer) on 3/2/21.Within 24-48 hrs patient had SOB. Patient went to ER & was Dx with unprovoked bilateral PE on 3/5/21. Patient has family history of VTE (father died of PE, mother had DVTs and was on warfarin). Patient was admitted from 3/6-3/7, discharged on apixaban. ID consult placed, ID physician recommended patient receive 2nd dose of COVID-19 vaccine in 21 days as scheduled.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Dyspnoea, Pulmonary embolism
Clinical narrative: pulmonary embolism Narrative:  Patient received first COVID-19 vaccine (Pfizer) on 3/2/21.Within 24-48 hrs patient had SOB. Patient went to ER & was Dx with unprovoked bilateral PE on 3/5/21. Patient has family history of VTE (father died of PE, mother had DVTs and was on warfarin). Patient was admitted from 3/6-3/7, discharged on apixaban. ID consult placed, ID physician recommended patient receive 2nd dose of COVID-19 vaccine in 21 days as scheduled.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Stridor
Clinical narrative: Vaccine administered 3/16/2021 at 3:30pm. Patient then had a localized reaction on left arm red swelling approximately 5-6cm at 3:40pm. Patient exhibited shortness of breath and continued worseness of localized reaction on left arm.O2 sats were monitored and showed 97%.  911 called at 3:45pm. 100mg of Solu-cortef administered IM at approximately 3:45 followed by 2 inhalations of albuterol at 3:48.. EMTs arrived at 3:55pm Patient given albuterol nebulizer and epipen 0.3 administered at 3:59. Patient transported to Medical Center at 4:10pm. ER Doctor was called by Dr and anaphylaxis treatment was discussed. ER called at 6:15PM Patient was stable and improving slowly.   Additional steroids and epipen given in hospital. Tried to call patient and left message on answering service. Patient called back and is improving in the CCU, 03/17 at 11:30AM. Spoke to CCU nurse and patient is stable. ENT examined nasal chords and no edema.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Erythema, Peripheral swelling, Skin reaction
Clinical narrative: Vaccine administered 3/16/2021 at 3:30pm. Patient then had a localized reaction on left arm red swelling approximately 5-6cm at 3:40pm. Patient exhibited shortness of breath and continued worseness of localized reaction on left arm.O2 sats were monitored and showed 97%.  911 called at 3:45pm. 100mg of Solu-cortef administered IM at approximately 3:45 followed by 2 inhalations of albuterol at 3:48.. EMTs arrived at 3:55pm Patient given albuterol nebulizer and epipen 0.3 administered at 3:59. Patient transported to Medical Center at 4:10pm. ER Doctor was called by Dr and anaphylaxis treatment was discussed. ER called at 6:15PM Patient was stable and improving slowly.   Additional steroids and epipen given in hospital. Tried to call patient and left message on answering service. Patient called back and is improving in the CCU, 03/17 at 11:30AM. Spoke to CCU nurse and patient is stable. ENT examined nasal chords and no edema.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Dysarthria, Eye disorder, Facial paralysis, Headache
Clinical narrative: Patient presented tot he hospital Emergency Department with right side facial numbness and drooping.  Patient was initially screened as a stroke patient but it was  ultimately diagnosed as Bell's Palsy.  Patient was treated and discharged home.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Patient presented tot he hospital Emergency Department with right side facial numbness and drooping.  Patient was initially screened as a stroke patient but it was  ultimately diagnosed as Bell's Palsy.  Patient was treated and discharged home.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia
Clinical narrative: Patient presented tot he hospital Emergency Department with right side facial numbness and drooping.  Patient was initially screened as a stroke patient but it was  ultimately diagnosed as Bell's Palsy.  Patient was treated and discharged home.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness; itching; swelling; pain at site
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: Redness; itching; swelling; pain at site
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Musculoskeletal chest pain, Pain
Clinical narrative: Patient waited at the hospital for 15 minutes as instructed.  He then drove back to school.  While driving, he experienced a moment of cold sweats, and then he blacked out completely.  He drove across traffic, through a field, across a road, through another field, and into a tree.  He did not regain consciousness until after impact.  He was transported by ambulance and was admitted to the hospital overnight.  Doctors ran numerous tests and found no cause for the blackout other than a reaction to the COVID vaccine.  His vehicle is a complete loss, and he is incredibly fortunate to be alive.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Road traffic accident, SARS-CoV-2 test negative, Syncope
Clinical narrative: Patient waited at the hospital for 15 minutes as instructed.  He then drove back to school.  While driving, he experienced a moment of cold sweats, and then he blacked out completely.  He drove across traffic, through a field, across a road, through another field, and into a tree.  He did not regain consciousness until after impact.  He was transported by ambulance and was admitted to the hospital overnight.  Doctors ran numerous tests and found no cause for the blackout other than a reaction to the COVID vaccine.  His vehicle is a complete loss, and he is incredibly fortunate to be alive.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood corticotrophin, Blood magnesium, Cold sweat, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: Patient waited at the hospital for 15 minutes as instructed.  He then drove back to school.  While driving, he experienced a moment of cold sweats, and then he blacked out completely.  He drove across traffic, through a field, across a road, through another field, and into a tree.  He did not regain consciousness until after impact.  He was transported by ambulance and was admitted to the hospital overnight.  Doctors ran numerous tests and found no cause for the blackout other than a reaction to the COVID vaccine.  His vehicle is a complete loss, and he is incredibly fortunate to be alive.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram spine, Computerised tomogram thorax, Differential white blood cell count, Drug screen, Echocardiogram
Clinical narrative: Patient waited at the hospital for 15 minutes as instructed.  He then drove back to school.  While driving, he experienced a moment of cold sweats, and then he blacked out completely.  He drove across traffic, through a field, across a road, through another field, and into a tree.  He did not regain consciousness until after impact.  He was transported by ambulance and was admitted to the hospital overnight.  Doctors ran numerous tests and found no cause for the blackout other than a reaction to the COVID vaccine.  His vehicle is a complete loss, and he is incredibly fortunate to be alive.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Lipase, Loss of consciousness, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: Patient waited at the hospital for 15 minutes as instructed.  He then drove back to school.  While driving, he experienced a moment of cold sweats, and then he blacked out completely.  He drove across traffic, through a field, across a road, through another field, and into a tree.  He did not regain consciousness until after impact.  He was transported by ambulance and was admitted to the hospital overnight.  Doctors ran numerous tests and found no cause for the blackout other than a reaction to the COVID vaccine.  His vehicle is a complete loss, and he is incredibly fortunate to be alive.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time, Road traffic accident, SARS-CoV-2 test, Thyroid function test, Ultrasound scan
Clinical narrative: Patient waited at the hospital for 15 minutes as instructed.  He then drove back to school.  While driving, he experienced a moment of cold sweats, and then he blacked out completely.  He drove across traffic, through a field, across a road, through another field, and into a tree.  He did not regain consciousness until after impact.  He was transported by ambulance and was admitted to the hospital overnight.  Doctors ran numerous tests and found no cause for the blackout other than a reaction to the COVID vaccine.  His vehicle is a complete loss, and he is incredibly fortunate to be alive.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urine analysis, Vaccination complication
Clinical narrative: Patient waited at the hospital for 15 minutes as instructed.  He then drove back to school.  While driving, he experienced a moment of cold sweats, and then he blacked out completely.  He drove across traffic, through a field, across a road, through another field, and into a tree.  He did not regain consciousness until after impact.  He was transported by ambulance and was admitted to the hospital overnight.  Doctors ran numerous tests and found no cause for the blackout other than a reaction to the COVID vaccine.  His vehicle is a complete loss, and he is incredibly fortunate to be alive.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Erythema
Clinical narrative: Patient pre-medicated for vaccine with 25mg Benadryl Immediately developed itchy hives. Went to the ER, was given Benadryl, Pepcid, and Decadron Symptoms resolved To follow up with PCP as needed, take Benadryl/Pepcid as needed
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Immediate post-injection reaction, Pruritus, Urticaria
Clinical narrative: Patient pre-medicated for vaccine with 25mg Benadryl Immediately developed itchy hives. Went to the ER, was given Benadryl, Pepcid, and Decadron Symptoms resolved To follow up with PCP as needed, take Benadryl/Pepcid as needed
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: hurt as much as the Shingrix vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group at vaccination was not reported but was captured as an adult as per vaccine indication. The patient information was not reported by the reporter. The patient received Shingrix vaccine in the fall and it hurt. The patient then got 2 doses of Pfizer Covid 19 vaccine and experienced local soreness at injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: got the Shingles shot and a short time later had shingles/ Suspected vaccination failure; shingles; was miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's parent. The age at vaccination was not reported. The patient received the Shingles shot and a short time later had shingles. The patient was miserable for two or three months. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Illness
Clinical narrative: Was "sick for a while"; Can't get over the tiredness / still exhausted; This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness and exhaustion. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the exhaustion was not recovered/not resolved.   The reporter considered the sickness and exhaustion to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's friend. The patient was non-diabetic (negative for diabetes) and she was healthy, active, exercised and had healthy diet. The patient was in her late 70's/early 80's. It was unknown if the reaction occurred after 1st or 2nd  shot of Shingrix. The age at vaccination was not reported.  The patient was not on lots of medicine. The patient was sick for a while and sickness has resolved but she could not get over the tiredness. The patient was still exhausted. The reporter provided limited information.  The consent to follow-up was requested. This was 1 of the 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021017003:Same reporter US-GLAXOSMITHKLINE-US2021017037:Same reporter US-GLAXOSMITHKLINE-US2021AMR018312:Same reporter. Case for friend 2 of 2.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Eye swelling, Heart rate, Heart rate increased
Clinical narrative: Dizzy; Weak; Throat are swollen; Oxygen levels dropped to 91%-92%/While she was flying her oxygen dropped; Heart rate was 141/heartrate was 106-110; Face swollen; Body ache; Eyes started swelling up; A spontaneous report was received from a consumer who is a 28-years-old female  patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events eyes swelling up, oxygen levels dropped to 91%-92%/ while she was flying her oxygen dropped, heartrate was 141/ heartrate was 106-110, face and throat are swollen, body aches/pain, dizziness and weakness.  The patient's medical history was not provided. Concomitant medications reported were propofol, benadryl and oxygen for drug use for unknown indication.  On 02-Feb-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.  On 02-Feb-2021 , the patient experienced the events eyes started swelling up, oxygen levels dropped to 91%-92%, heartrate was 141, face and throat are swollen, body aches, had pain, while the patient was flying her oxygen dropped, the patient takes propofol 10mg to reduce heartrate  but did not work as well as it normally does was around 110, her oxygen saturation was 96% when she landed, heartrate was 106-110.   On 03-Feb-2021, the patient took some benadryl to help with side effects. She was still dizzy and weak.  Treatment details included Benadryl and Propofol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events oxygen levels dropped to 91%-92% was considered resolved on 03 Feb 2021.  The outcome of events, eyes started swelling up was unknown, heartrate was 141,face and throat are swollen ,body aches had pain ,while she was flying her oxygen dropped, her oxygen saturation was 96% when she landed, heartrate was 106-110, dizziness, weakness was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Oxygen saturation decreased, Pain, Pharyngeal swelling, Swelling face
Clinical narrative: Dizzy; Weak; Throat are swollen; Oxygen levels dropped to 91%-92%/While she was flying her oxygen dropped; Heart rate was 141/heartrate was 106-110; Face swollen; Body ache; Eyes started swelling up; A spontaneous report was received from a consumer who is a 28-years-old female  patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events eyes swelling up, oxygen levels dropped to 91%-92%/ while she was flying her oxygen dropped, heartrate was 141/ heartrate was 106-110, face and throat are swollen, body aches/pain, dizziness and weakness.  The patient's medical history was not provided. Concomitant medications reported were propofol, benadryl and oxygen for drug use for unknown indication.  On 02-Feb-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.  On 02-Feb-2021 , the patient experienced the events eyes started swelling up, oxygen levels dropped to 91%-92%, heartrate was 141, face and throat are swollen, body aches, had pain, while the patient was flying her oxygen dropped, the patient takes propofol 10mg to reduce heartrate  but did not work as well as it normally does was around 110, her oxygen saturation was 96% when she landed, heartrate was 106-110.   On 03-Feb-2021, the patient took some benadryl to help with side effects. She was still dizzy and weak.  Treatment details included Benadryl and Propofol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events oxygen levels dropped to 91%-92% was considered resolved on 03 Feb 2021.  The outcome of events, eyes started swelling up was unknown, heartrate was 141,face and throat are swollen ,body aches had pain ,while she was flying her oxygen dropped, her oxygen saturation was 96% when she landed, heartrate was 106-110, dizziness, weakness was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Paraesthesia, Pruritus, Urticaria
Clinical narrative: cyst behind ear and after vaccination got bigger; itching on body; hives; tingling hands; A spontaneous report was received from a 37-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cyst behind ear and after vaccination got bigger, itching on body, hives and tingling hands.  The patient's medical history was not provided. No concomitant product use was reported.  On 24-Feb-2021, the patient received his first dose of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 3-March-2021, the patient reported that his body started itching, mainly on his hands and torso and he broke out in hives. The patient wanted to know if this could be related to the vaccine or something he ate. He also mentioned that before the vaccine he had a small cyst behind his left ear, the same side he received his vaccine on, but after the vaccine his cyst got bigger. He was also noticing that his hands will tingle throughout the day, it comes and goes. Treatment for the events,  included diphenhydramine which helped him with the itching and hives. Patient would like to know if he should get the second dose of the vaccine.  Action taken with mRNA-1273 was unknown.  The outcome of all the events,cyst behind ear and after vaccination got bigger, itching on body, hives and tingling hands were considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.