chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, Dizziness, Dyspnoea, Erythema, Flushing
Clinical narrative: Anaphylactic reaction; Dizziness; Short of breath; Skin flushed; Sweating; Pulse weak; Erythematous rash; This is a spontaneous report from a contactable other health professional via US FDA (The regulatory authority report number (VAERS Number) is 902557). A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscular in right arm on 15Dec2020 17:50 at single dose for COVID-19 immunization. Medical history included Chronic or long-standing Health condition: low blood sugar, low blood pressure from an unspecified date and ongoing. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), vitamin d nos (VITAMIN D) and Women's Multivitamin. The patient experienced anaphylactic reaction, short of breath, pulse weak, skin flushed, sweating, dizziness, erythematous rash all on 15Dec2020 18:00 with outcome of not recovered. It was reported that she was sitting, and felt short of breath without wheeze or tightness in the chest or throat. She stood up, and then felt tunneling. Assisted to chair and floor. Pulse weak, skin flushed and red. She refused epi at first. So benedryll 25mg po with apple juice was given. She said she just had a big meal 30 min prior, but her blood sugar was checked. It was 85. 10 min after the first SOB feeling, it returned. BP was recorded as 160/100 on 15Dec2020. The event erythematous rash was non-serious, the other events were all serious as caused hospitalization for 1 day and life-threatening. Medical tests and laboratory results related to the adverse events on an unspecified date: Initial CBC, BMP, CRP, Troponin- remarkable only for mild hypokalemia, and mild elevated AST/ALT (50/72). TSH mildly elevated at 8.83, but normal FT4, ED visit, blood draw, monitoring. Anaphylactic reaction onset 10 minutes after Injection. Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treatment with Diphenhydramine, followed by 0.3mg epinephrine intramuscular w/improvement of symptoms. Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip. She had recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine. Patient remained on epi drip and is currently admitted to critical care unit for ongoing treatment and observation.  Follow-up (19Jan2021): New information received in response to the mail trail sent regarding the confirmation, included: reporter detail information updated, medical history updated, date of lab data updated and case narrative was added.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count abnormal, Hyperhidrosis, Hypokalaemia, Intensive care, Metabolic function test
Clinical narrative: Anaphylactic reaction; Dizziness; Short of breath; Skin flushed; Sweating; Pulse weak; Erythematous rash; This is a spontaneous report from a contactable other health professional via US FDA (The regulatory authority report number (VAERS Number) is 902557). A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscular in right arm on 15Dec2020 17:50 at single dose for COVID-19 immunization. Medical history included Chronic or long-standing Health condition: low blood sugar, low blood pressure from an unspecified date and ongoing. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), vitamin d nos (VITAMIN D) and Women's Multivitamin. The patient experienced anaphylactic reaction, short of breath, pulse weak, skin flushed, sweating, dizziness, erythematous rash all on 15Dec2020 18:00 with outcome of not recovered. It was reported that she was sitting, and felt short of breath without wheeze or tightness in the chest or throat. She stood up, and then felt tunneling. Assisted to chair and floor. Pulse weak, skin flushed and red. She refused epi at first. So benedryll 25mg po with apple juice was given. She said she just had a big meal 30 min prior, but her blood sugar was checked. It was 85. 10 min after the first SOB feeling, it returned. BP was recorded as 160/100 on 15Dec2020. The event erythematous rash was non-serious, the other events were all serious as caused hospitalization for 1 day and life-threatening. Medical tests and laboratory results related to the adverse events on an unspecified date: Initial CBC, BMP, CRP, Troponin- remarkable only for mild hypokalemia, and mild elevated AST/ALT (50/72). TSH mildly elevated at 8.83, but normal FT4, ED visit, blood draw, monitoring. Anaphylactic reaction onset 10 minutes after Injection. Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treatment with Diphenhydramine, followed by 0.3mg epinephrine intramuscular w/improvement of symptoms. Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip. She had recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine. Patient remained on epi drip and is currently admitted to critical care unit for ongoing treatment and observation.  Follow-up (19Jan2021): New information received in response to the mail trail sent regarding the confirmation, included: reporter detail information updated, medical history updated, date of lab data updated and case narrative was added.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal, Rash erythematous, Thyroxine free normal, Troponin normal, Tunnel vision
Clinical narrative: Anaphylactic reaction; Dizziness; Short of breath; Skin flushed; Sweating; Pulse weak; Erythematous rash; This is a spontaneous report from a contactable other health professional via US FDA (The regulatory authority report number (VAERS Number) is 902557). A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscular in right arm on 15Dec2020 17:50 at single dose for COVID-19 immunization. Medical history included Chronic or long-standing Health condition: low blood sugar, low blood pressure from an unspecified date and ongoing. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), vitamin d nos (VITAMIN D) and Women's Multivitamin. The patient experienced anaphylactic reaction, short of breath, pulse weak, skin flushed, sweating, dizziness, erythematous rash all on 15Dec2020 18:00 with outcome of not recovered. It was reported that she was sitting, and felt short of breath without wheeze or tightness in the chest or throat. She stood up, and then felt tunneling. Assisted to chair and floor. Pulse weak, skin flushed and red. She refused epi at first. So benedryll 25mg po with apple juice was given. She said she just had a big meal 30 min prior, but her blood sugar was checked. It was 85. 10 min after the first SOB feeling, it returned. BP was recorded as 160/100 on 15Dec2020. The event erythematous rash was non-serious, the other events were all serious as caused hospitalization for 1 day and life-threatening. Medical tests and laboratory results related to the adverse events on an unspecified date: Initial CBC, BMP, CRP, Troponin- remarkable only for mild hypokalemia, and mild elevated AST/ALT (50/72). TSH mildly elevated at 8.83, but normal FT4, ED visit, blood draw, monitoring. Anaphylactic reaction onset 10 minutes after Injection. Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treatment with Diphenhydramine, followed by 0.3mg epinephrine intramuscular w/improvement of symptoms. Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip. She had recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine. Patient remained on epi drip and is currently admitted to critical care unit for ongoing treatment and observation.  Follow-up (19Jan2021): New information received in response to the mail trail sent regarding the confirmation, included: reporter detail information updated, medical history updated, date of lab data updated and case narrative was added.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Burning sensation, Chest X-ray normal, Chest pain, Dyspnoea
Clinical narrative: The next morning after I had trouble getting up.  I was achy and had a 99.7 fever.  Took tylenol and rested.  A few hours later the symptoms got worse and worse an my body  ached so bad I could barely walk.  The fever elevated as high as 103 during that time.  And I had what felt like pressure on my neck which made my voice sounded really rough.  I had chest pains, rapid HR and SOB  and the symptoms got so bad I went to the ER where I remained for about 8hrs.  While there I started getting a really bad headache which lasted from that Sun after to the end of the week on Friday.   Benedryl, pepcid, tylenol was given.  About 9:30pm I was released with a prescription for the headache and advised to take benedryl.  Once home I noticed my arm was swollen and white in the center.  I got a rash on that arm that carried to my face and was itchy and burning.  I had lymph nodes that devoloped under both arm pits but the side where the injection was given hurt worse than the other. Had to wear the holter monitor for a week d/t the elevated HR which in turn made the healthcare specialist prescribe metroprol to help lower the HR but to date I am still having issues with the rapid HR.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Eosinophil count decreased, Full blood count, Headache, Heart rate increased
Clinical narrative: The next morning after I had trouble getting up.  I was achy and had a 99.7 fever.  Took tylenol and rested.  A few hours later the symptoms got worse and worse an my body  ached so bad I could barely walk.  The fever elevated as high as 103 during that time.  And I had what felt like pressure on my neck which made my voice sounded really rough.  I had chest pains, rapid HR and SOB  and the symptoms got so bad I went to the ER where I remained for about 8hrs.  While there I started getting a really bad headache which lasted from that Sun after to the end of the week on Friday.   Benedryl, pepcid, tylenol was given.  About 9:30pm I was released with a prescription for the headache and advised to take benedryl.  Once home I noticed my arm was swollen and white in the center.  I got a rash on that arm that carried to my face and was itchy and burning.  I had lymph nodes that devoloped under both arm pits but the side where the injection was given hurt worse than the other. Had to wear the holter monitor for a week d/t the elevated HR which in turn made the healthcare specialist prescribe metroprol to help lower the HR but to date I am still having issues with the rapid HR.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Injection site pain, Lymphadenopathy, Mobility decreased, Muscle tightness
Clinical narrative: The next morning after I had trouble getting up.  I was achy and had a 99.7 fever.  Took tylenol and rested.  A few hours later the symptoms got worse and worse an my body  ached so bad I could barely walk.  The fever elevated as high as 103 during that time.  And I had what felt like pressure on my neck which made my voice sounded really rough.  I had chest pains, rapid HR and SOB  and the symptoms got so bad I went to the ER where I remained for about 8hrs.  While there I started getting a really bad headache which lasted from that Sun after to the end of the week on Friday.   Benedryl, pepcid, tylenol was given.  About 9:30pm I was released with a prescription for the headache and advised to take benedryl.  Once home I noticed my arm was swollen and white in the center.  I got a rash on that arm that carried to my face and was itchy and burning.  I had lymph nodes that devoloped under both arm pits but the side where the injection was given hurt worse than the other. Had to wear the holter monitor for a week d/t the elevated HR which in turn made the healthcare specialist prescribe metroprol to help lower the HR but to date I am still having issues with the rapid HR.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count increased, Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: The next morning after I had trouble getting up.  I was achy and had a 99.7 fever.  Took tylenol and rested.  A few hours later the symptoms got worse and worse an my body  ached so bad I could barely walk.  The fever elevated as high as 103 during that time.  And I had what felt like pressure on my neck which made my voice sounded really rough.  I had chest pains, rapid HR and SOB  and the symptoms got so bad I went to the ER where I remained for about 8hrs.  While there I started getting a really bad headache which lasted from that Sun after to the end of the week on Friday.   Benedryl, pepcid, tylenol was given.  About 9:30pm I was released with a prescription for the headache and advised to take benedryl.  Once home I noticed my arm was swollen and white in the center.  I got a rash on that arm that carried to my face and was itchy and burning.  I had lymph nodes that devoloped under both arm pits but the side where the injection was given hurt worse than the other. Had to wear the holter monitor for a week d/t the elevated HR which in turn made the healthcare specialist prescribe metroprol to help lower the HR but to date I am still having issues with the rapid HR.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: The next morning after I had trouble getting up.  I was achy and had a 99.7 fever.  Took tylenol and rested.  A few hours later the symptoms got worse and worse an my body  ached so bad I could barely walk.  The fever elevated as high as 103 during that time.  And I had what felt like pressure on my neck which made my voice sounded really rough.  I had chest pains, rapid HR and SOB  and the symptoms got so bad I went to the ER where I remained for about 8hrs.  While there I started getting a really bad headache which lasted from that Sun after to the end of the week on Friday.   Benedryl, pepcid, tylenol was given.  About 9:30pm I was released with a prescription for the headache and advised to take benedryl.  Once home I noticed my arm was swollen and white in the center.  I got a rash on that arm that carried to my face and was itchy and burning.  I had lymph nodes that devoloped under both arm pits but the side where the injection was given hurt worse than the other. Had to wear the holter monitor for a week d/t the elevated HR which in turn made the healthcare specialist prescribe metroprol to help lower the HR but to date I am still having issues with the rapid HR.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Hyperhidrosis, Hypoaesthesia oral, Lip swelling
Clinical narrative: I received the moderna vaccine at 1245 on 12/26/20 . I stayed in the hospital 15 minutes with no problems. When I was driving home at 1310, I developed itching to my face and head, I felt like my lower lip was numb and swollen. Like when you go to the dentist and get novocaine. I drove home and took 50 mg benadryl and called the ER. I went to the local ER and  felt hot, diaphoretic, anxious and was given 40 mg Prednisone orally. I was observed for one hour. NO SOB occurred. I was discharged home with Prednisone 20 mg daily for 8 days, epi pen and told to take Benadryl and pepcid.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I received the moderna vaccine at 1245 on 12/26/20 . I stayed in the hospital 15 minutes with no problems. When I was driving home at 1310, I developed itching to my face and head, I felt like my lower lip was numb and swollen. Like when you go to the dentist and get novocaine. I drove home and took 50 mg benadryl and called the ER. I went to the local ER and  felt hot, diaphoretic, anxious and was given 40 mg Prednisone orally. I was observed for one hour. NO SOB occurred. I was discharged home with Prednisone 20 mg daily for 8 days, epi pen and told to take Benadryl and pepcid.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Left arm pain, redness & swelling at injection site
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia oral, Magnetic resonance imaging head normal, Pain in extremity
Clinical narrative: Had soreness in the arm for two days. On the 26th, evening, I went to take drink of water and some of spilled down my face and I thought I just had a fat lip. 27th, I went to work and went to lunch at noon, I went to eat food and I noticed that my mouth -right side was numb. I thought something might be wrong and someone told me that my right side of my face looked slack. Saw on Dec 28, Dr. - had already scheduled an appt for follow up for diabetes - and I told her about my symptoms and she looked at my face and had me smile and crinkle my face. She sent me to my doctor downstairs (she had the nurse call downstairs and told them I needed to be seen that day). I went downstairs and I saw my doctor and my doctor scheduled an MRI on 28th at 7 PM and also ordered for me to take Prednisone and Valtrex. MRI result came back fine. I responded well to both of these meds - I started to get muscle control back into my face. It shot my sugar numbers up but solved the other problem in about 15 days I could shut my eyes without delay and I feel like I have muscle control in my face. January 22, I got the second dose and so far I don't notice anything different.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: Throat like having a lump; Throat like a little tight; Little tightness in chest; Tongue was swollen; Allergic reaction; Injection site black and blue; Injection site hot to touch; Injection site swollen; A spontaneous report was received from a 18 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction, throat like having a lump, throat like a little tight, little tightness in the chest, tongue was swollen, injection site swollen, injection site black and blue, and injection site hot to touch.  The patient's medical history, as provided by the reporter, included allergy to lobster, peas, and pollen. Concomitant medications reported included amitriptyline, birth control pills (unspecified) and cetirizine.      On 31 Dec 2020 at 7:40 am, approximately 10-15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving the vaccine, the patient was monitored for 15 minutes. Within the last minutes, the patient felt like her throat had a lump and was a little tight. She also had a little tightness in her chest and a swollen tongue. The injection site was swollen, black and blue, and hot to touch. The patient was wondering if any of the components of the vaccine might have been the cause of the allergic reaction. Treatment for the events included diphenhydramine, prednisone and epinephrine. The patient was monitored until 12:00 pm.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, allergic reaction, throat like having a lump, throat like a little tight, little tightness in the chest, tongue was swollen, were considered resolved on 31 Dec 2020. The outcome of the events, injection site swollen, injection site black and blue, and injection site hot to touch, were not resolved.; Reporter's Comments: This case concerns a 18 year old female patient with medical history of allergy to lobster, peas, and pollen, who experienced serious unexpected events of Sensation of foreign body, Throat tightness, Chest discomfort, Swollen tongue, and Drug hypersensitivity, non-serious unexpected events of Injection site discolouration and Injection site warmth, and a non-serious expected event of Injection site swelling. The events occurred about 15 minutes after the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A). Treatment with diphenhydramine, prednisone and epinephrine was performed and the events of Sensation of foreign body, Throat tightness, Chest discomfort, Swollen tongue, and Drug hypersensitivity resolved on the same day. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Drug hypersensitivity, Injection site discolouration, Injection site swelling, Injection site warmth
Clinical narrative: Throat like having a lump; Throat like a little tight; Little tightness in chest; Tongue was swollen; Allergic reaction; Injection site black and blue; Injection site hot to touch; Injection site swollen; A spontaneous report was received from a 18 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction, throat like having a lump, throat like a little tight, little tightness in the chest, tongue was swollen, injection site swollen, injection site black and blue, and injection site hot to touch.  The patient's medical history, as provided by the reporter, included allergy to lobster, peas, and pollen. Concomitant medications reported included amitriptyline, birth control pills (unspecified) and cetirizine.      On 31 Dec 2020 at 7:40 am, approximately 10-15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving the vaccine, the patient was monitored for 15 minutes. Within the last minutes, the patient felt like her throat had a lump and was a little tight. She also had a little tightness in her chest and a swollen tongue. The injection site was swollen, black and blue, and hot to touch. The patient was wondering if any of the components of the vaccine might have been the cause of the allergic reaction. Treatment for the events included diphenhydramine, prednisone and epinephrine. The patient was monitored until 12:00 pm.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, allergic reaction, throat like having a lump, throat like a little tight, little tightness in the chest, tongue was swollen, were considered resolved on 31 Dec 2020. The outcome of the events, injection site swollen, injection site black and blue, and injection site hot to touch, were not resolved.; Reporter's Comments: This case concerns a 18 year old female patient with medical history of allergy to lobster, peas, and pollen, who experienced serious unexpected events of Sensation of foreign body, Throat tightness, Chest discomfort, Swollen tongue, and Drug hypersensitivity, non-serious unexpected events of Injection site discolouration and Injection site warmth, and a non-serious expected event of Injection site swelling. The events occurred about 15 minutes after the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A). Treatment with diphenhydramine, prednisone and epinephrine was performed and the events of Sensation of foreign body, Throat tightness, Chest discomfort, Swollen tongue, and Drug hypersensitivity resolved on the same day. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensation of foreign body, Swollen tongue, Throat tightness
Clinical narrative: Throat like having a lump; Throat like a little tight; Little tightness in chest; Tongue was swollen; Allergic reaction; Injection site black and blue; Injection site hot to touch; Injection site swollen; A spontaneous report was received from a 18 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction, throat like having a lump, throat like a little tight, little tightness in the chest, tongue was swollen, injection site swollen, injection site black and blue, and injection site hot to touch.  The patient's medical history, as provided by the reporter, included allergy to lobster, peas, and pollen. Concomitant medications reported included amitriptyline, birth control pills (unspecified) and cetirizine.      On 31 Dec 2020 at 7:40 am, approximately 10-15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving the vaccine, the patient was monitored for 15 minutes. Within the last minutes, the patient felt like her throat had a lump and was a little tight. She also had a little tightness in her chest and a swollen tongue. The injection site was swollen, black and blue, and hot to touch. The patient was wondering if any of the components of the vaccine might have been the cause of the allergic reaction. Treatment for the events included diphenhydramine, prednisone and epinephrine. The patient was monitored until 12:00 pm.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, allergic reaction, throat like having a lump, throat like a little tight, little tightness in the chest, tongue was swollen, were considered resolved on 31 Dec 2020. The outcome of the events, injection site swollen, injection site black and blue, and injection site hot to touch, were not resolved.; Reporter's Comments: This case concerns a 18 year old female patient with medical history of allergy to lobster, peas, and pollen, who experienced serious unexpected events of Sensation of foreign body, Throat tightness, Chest discomfort, Swollen tongue, and Drug hypersensitivity, non-serious unexpected events of Injection site discolouration and Injection site warmth, and a non-serious expected event of Injection site swelling. The events occurred about 15 minutes after the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A). Treatment with diphenhydramine, prednisone and epinephrine was performed and the events of Sensation of foreign body, Throat tightness, Chest discomfort, Swollen tongue, and Drug hypersensitivity resolved on the same day. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Oropharyngeal discomfort
Clinical narrative: Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Feeling hot, Hyperhidrosis
Clinical narrative: Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Throat tightness
Clinical narrative: Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Patient expired - autopsy preformed - cause of death not related to COVID-19 vaccination according to  coroner.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Hot flush, Lethargy, Nausea, Respiratory rate decreased
Clinical narrative: Patient expired - autopsy preformed - cause of death not related to COVID-19 vaccination according to  coroner.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Patient expired - autopsy preformed - cause of death not related to COVID-19 vaccination according to  coroner.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Death
Clinical narrative: Patient expired - autopsy preformed - cause of death not related to COVID-19 vaccination according to  coroner.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: dizziness, tachycardia (HR=150's) elevated BP( 160/120)  Uncontrollable , extreme body shakes from head to toe.  After hydrating, shaking continued and worsened. Vaccine staff took me to ED for monitoring. IV started and fluids given. Shaking resolved after about 30 minutes. I was discharged and went home, no further incident that evening.   Day after vaccine received, 1230pm, I experienced the same sudden onset of symptoms. Took Benadryl po, drank 3 bottles of water ( as I was told the day before to do) Extreme uncontrollable shaking continued after 45 minutes of taking Benadryl. I went in to ED for monitoring again. B/P elevated, Heart rate increased. with palpitations.  I was evaluated for COVID Rapid test and it was negative. Covid antibodies were also negative at that time. Several other labs and testing done.  Everything resolved after 1 hour of ED monitoring. I was discharged after 3-4 hours and no further symptoms noted.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Laboratory test, Palpitations
Clinical narrative: dizziness, tachycardia (HR=150's) elevated BP( 160/120)  Uncontrollable , extreme body shakes from head to toe.  After hydrating, shaking continued and worsened. Vaccine staff took me to ED for monitoring. IV started and fluids given. Shaking resolved after about 30 minutes. I was discharged and went home, no further incident that evening.   Day after vaccine received, 1230pm, I experienced the same sudden onset of symptoms. Took Benadryl po, drank 3 bottles of water ( as I was told the day before to do) Extreme uncontrollable shaking continued after 45 minutes of taking Benadryl. I went in to ED for monitoring again. B/P elevated, Heart rate increased. with palpitations.  I was evaluated for COVID Rapid test and it was negative. Covid antibodies were also negative at that time. Several other labs and testing done.  Everything resolved after 1 hour of ED monitoring. I was discharged after 3-4 hours and no further symptoms noted.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative, Tachycardia, Tremor
Clinical narrative: dizziness, tachycardia (HR=150's) elevated BP( 160/120)  Uncontrollable , extreme body shakes from head to toe.  After hydrating, shaking continued and worsened. Vaccine staff took me to ED for monitoring. IV started and fluids given. Shaking resolved after about 30 minutes. I was discharged and went home, no further incident that evening.   Day after vaccine received, 1230pm, I experienced the same sudden onset of symptoms. Took Benadryl po, drank 3 bottles of water ( as I was told the day before to do) Extreme uncontrollable shaking continued after 45 minutes of taking Benadryl. I went in to ED for monitoring again. B/P elevated, Heart rate increased. with palpitations.  I was evaluated for COVID Rapid test and it was negative. Covid antibodies were also negative at that time. Several other labs and testing done.  Everything resolved after 1 hour of ED monitoring. I was discharged after 3-4 hours and no further symptoms noted.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest pain, Erythema, Hyperhidrosis, Palpitations
Clinical narrative: Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received  Benadryl 25mg orally  and chest tightness and heaviness received 2nd dose  Benadryl 25mg . EMS /cardiac monitored and was transferred  to a Hospital.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Syncope
Clinical narrative: Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received  Benadryl 25mg orally  and chest tightness and heaviness received 2nd dose  Benadryl 25mg . EMS /cardiac monitored and was transferred  to a Hospital.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Cardiac monitoring, Chest discomfort, Feeling hot, Flushing
Clinical narrative: Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received  Benadryl 25mg orally  and chest tightness and heaviness received 2nd dose  Benadryl 25mg . EMS /cardiac monitored and was transferred  to a Hospital.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pruritus
Clinical narrative: Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received  Benadryl 25mg orally  and chest tightness and heaviness received 2nd dose  Benadryl 25mg . EMS /cardiac monitored and was transferred  to a Hospital.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G, Cough, Diarrhoea, Fatigue, Full blood count
Clinical narrative: ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue  12/22/2020 sever diarrhea , 12/26/2020 feeling worse and worse and  tested on 12/26/2020  on 12/28-29/2020 shortness of breath and admitted on 12/31/2020
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Liver function test, Metabolic function test, SARS-CoV-2 antibody test, SARS-CoV-2 test positive, T-lymphocyte count
Clinical narrative: ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue  12/22/2020 sever diarrhea , 12/26/2020 feeling worse and worse and  tested on 12/26/2020  on 12/28-29/2020 shortness of breath and admitted on 12/31/2020
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue  12/22/2020 sever diarrhea , 12/26/2020 feeling worse and worse and  tested on 12/26/2020  on 12/28-29/2020 shortness of breath and admitted on 12/31/2020
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a Contactable nurse reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wanted to know recommendations for receiving the second dose after having a possible reaction from the first dose. She developed hives 5 days after receiving the vaccine. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient stated his arm swelled up after receiving the PNEUMOV AX 23 vaccine.; This spontaneous report was received from a pharmacist referring to a 66 year old male patient with chronic Pain. The patient's historical drugs included drug reactions or allergies to penicillin. Concomitant therapies included trazodone hydrochloride, unspecified anti-inflammatories and pregabalin (LYRICA).   On 08-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, via intramuscular route once(strength, and anatomical location were unknown) with lot # S036495, and expiration date 13-SEP-2021 for vacciantion.   On approximately,12-JAN-2021(reported as "today"), the patient went into the pharmacy  and made the pharmacist aware that his arm swelled up (peripheral swelling) after receiving the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine. He went to the emergency room and they sent him home with a prescription for Prednisone.   At the time of the report, the patient recovered from the peripheral swelling on an unknown date. The reporter did not mention the causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: M
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: The patient stated his arm swelled up after receiving the PNEUMOV AX 23 vaccine.; This spontaneous report was received from a pharmacist referring to a 66 year old male patient with chronic Pain. The patient's historical drugs included drug reactions or allergies to penicillin. Concomitant therapies included trazodone hydrochloride, unspecified anti-inflammatories and pregabalin (LYRICA).   On 08-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, via intramuscular route once(strength, and anatomical location were unknown) with lot # S036495, and expiration date 13-SEP-2021 for vacciantion.   On approximately,12-JAN-2021(reported as "today"), the patient went into the pharmacy  and made the pharmacist aware that his arm swelled up (peripheral swelling) after receiving the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine. He went to the emergency room and they sent him home with a prescription for Prednisone.   At the time of the report, the patient recovered from the peripheral swelling on an unknown date. The reporter did not mention the causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: in a medically induced coma; not being able to breathe; passed away after the second dose of the Pfizer vaccine; more complications to his vital organs started to occur and they began to shut down; This is a spontaneous report from a contactable consumer (patient's cousin). A male patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on 05Jan2021 11:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient passed away after the second dose of the Pfizer vaccine. He was a TC/ X-Ray Tech. He received the vaccine on 05Jan2021 at 11:30 am. A few hours after the vaccine he complained about not being able to breathe. On Wednesday, he was put on a ventilator and in a medically induced coma. After a couple of days of major complications and the  hospital not being equipped to handle his complications, he was transferred to another hospital. Although it was the correct move, more complications to his vital organs started to occur and they began to shut down. By 09Jan2021, Saturday, he passed. He had no compromised health issues prior to the vaccine. He was also COVID free. The patient died on 09Jan2021. It was not reported if an autopsy was performed. The outcome of other events was unknown.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away after the second dose of the Pfizer vaccine
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Bilevel positive airway pressure, Computerised tomogram, Death, Dialysis
Clinical narrative: in a medically induced coma; not being able to breathe; passed away after the second dose of the Pfizer vaccine; more complications to his vital organs started to occur and they began to shut down; This is a spontaneous report from a contactable consumer (patient's cousin). A male patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on 05Jan2021 11:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient passed away after the second dose of the Pfizer vaccine. He was a TC/ X-Ray Tech. He received the vaccine on 05Jan2021 at 11:30 am. A few hours after the vaccine he complained about not being able to breathe. On Wednesday, he was put on a ventilator and in a medically induced coma. After a couple of days of major complications and the  hospital not being equipped to handle his complications, he was transferred to another hospital. Although it was the correct move, more complications to his vital organs started to occur and they began to shut down. By 09Jan2021, Saturday, he passed. He had no compromised health issues prior to the vaccine. He was also COVID free. The patient died on 09Jan2021. It was not reported if an autopsy was performed. The outcome of other events was unknown.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away after the second dose of the Pfizer vaccine
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Endotracheal intubation, SARS-CoV-2 test negative
Clinical narrative: in a medically induced coma; not being able to breathe; passed away after the second dose of the Pfizer vaccine; more complications to his vital organs started to occur and they began to shut down; This is a spontaneous report from a contactable consumer (patient's cousin). A male patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on 05Jan2021 11:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient passed away after the second dose of the Pfizer vaccine. He was a TC/ X-Ray Tech. He received the vaccine on 05Jan2021 at 11:30 am. A few hours after the vaccine he complained about not being able to breathe. On Wednesday, he was put on a ventilator and in a medically induced coma. After a couple of days of major complications and the  hospital not being equipped to handle his complications, he was transferred to another hospital. Although it was the correct move, more complications to his vital organs started to occur and they began to shut down. By 09Jan2021, Saturday, he passed. He had no compromised health issues prior to the vaccine. He was also COVID free. The patient died on 09Jan2021. It was not reported if an autopsy was performed. The outcome of other events was unknown.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away after the second dose of the Pfizer vaccine
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dyspnoea, Mechanical ventilation, Medical induction of coma, Multiple organ dysfunction syndrome
Clinical narrative: in a medically induced coma; not being able to breathe; passed away after the second dose of the Pfizer vaccine; more complications to his vital organs started to occur and they began to shut down; This is a spontaneous report from a contactable consumer (patient's cousin). A male patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on 05Jan2021 11:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient passed away after the second dose of the Pfizer vaccine. He was a TC/ X-Ray Tech. He received the vaccine on 05Jan2021 at 11:30 am. A few hours after the vaccine he complained about not being able to breathe. On Wednesday, he was put on a ventilator and in a medically induced coma. After a couple of days of major complications and the  hospital not being equipped to handle his complications, he was transferred to another hospital. Although it was the correct move, more complications to his vital organs started to occur and they began to shut down. By 09Jan2021, Saturday, he passed. He had no compromised health issues prior to the vaccine. He was also COVID free. The patient died on 09Jan2021. It was not reported if an autopsy was performed. The outcome of other events was unknown.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away after the second dose of the Pfizer vaccine
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: in a medically induced coma; not being able to breathe; passed away after the second dose of the Pfizer vaccine; more complications to his vital organs started to occur and they began to shut down; This is a spontaneous report from a contactable consumer (patient's cousin). A male patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on 05Jan2021 11:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient passed away after the second dose of the Pfizer vaccine. He was a TC/ X-Ray Tech. He received the vaccine on 05Jan2021 at 11:30 am. A few hours after the vaccine he complained about not being able to breathe. On Wednesday, he was put on a ventilator and in a medically induced coma. After a couple of days of major complications and the  hospital not being equipped to handle his complications, he was transferred to another hospital. Although it was the correct move, more complications to his vital organs started to occur and they began to shut down. By 09Jan2021, Saturday, he passed. He had no compromised health issues prior to the vaccine. He was also COVID free. The patient died on 09Jan2021. It was not reported if an autopsy was performed. The outcome of other events was unknown.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away after the second dose of the Pfizer vaccine
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia, Tremor
Clinical narrative: Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Muscle aches; Fever finally broke at 3pm on the next day 17 hours after symptoms began; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on the left arm on 09Jan2021 at 11:00, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 22Dec2020 at 11:00 for COVID-19 immunization. On 09Jan2021, the patient had shot at 11am with no reaction then at 10pm when started shaking/shivering violently for 2 hours and then developed very bad headache, muscle aches. The patient's fever up to 101 then the fever finally broke at 3pm on the next day (10Jan2021) 17 hours after symptoms began. As treatment, patient took Tylenol and Excedrin for headache, muscles aches and fever. No treatment was reported for the events shaking/shivering. The outcome of the event fever was recovered on 10Jan2021 15:00 while the rest of the events was recovered on Jan2021.