chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pain assessment
Clinical narrative: herpes zoster blisters on my abdomen with the accompanying pain; accompanying pain / pain I am having which on a scale of 1-10 is a 15; herpes zoster blisters on my abdomen; This case was reported by a consumer and described the occurrence of herpes zoster in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received the 1st dose of Shingrix. On 22nd December 2020, 4 days after receiving Shingrix, the patient experienced herpes zoster, pain and blister. The patient was treated with pregabalin (Lyrica). On an unknown date, the outcome of the herpes zoster, pain and blister were unknown.   It was unknown if the reporter considered the herpes zoster, pain and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 70 or 71 years. The patient received Shingrix and 4 days after receiving the injection developed herpes zoster blisters on abdomen with the accompanying pain.  The patient been put on Lyrica to see if that would help with the pain which on a scale of 1 to 10 was a 15. The patient would not having the second injection.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site ulcer, Injection site vesicles
Clinical narrative: Cellulitis with blisters, redness, swelling, painful, and fever.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Cellulitis, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Cellulitis with blisters, redness, swelling, painful, and fever.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Cellulitis with blisters, redness, swelling, painful, and fever.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Feeling abnormal, Hypotension, Injection site erythema, Injection site pruritus
Clinical narrative: Moderna COVID-19 Vaccine EUA  After 1st dose of Moderna COVID vaccine. Per chart notes, pt tolerated well, had initial light headedness but BP WNL and pt felt normal after 20 minutes.  Per pt report 2 weeks later, pt heard rinigng in her ears w/in first 12 minutes and needed to lay down. BP was 149/88 which was high for pt. 10 minutes later she felt no worse, but still felt "icky". This feeling lasted 75 minutes, after which pt returned to work. Pt had 12/30 off of work and felt fine until 12/31 when she had joint pain in her pelvis. Days 4 and 5 (1/1/21 and 1/2/21) she had ringing in her ears and BP as 105/56 (low for her). Symptoms now resolved.  1/26/2021: Pt received 2nd dose of COVID vaccine without issue.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Injection site warmth, Tinnitus
Clinical narrative: Moderna COVID-19 Vaccine EUA  After 1st dose of Moderna COVID vaccine. Per chart notes, pt tolerated well, had initial light headedness but BP WNL and pt felt normal after 20 minutes.  Per pt report 2 weeks later, pt heard rinigng in her ears w/in first 12 minutes and needed to lay down. BP was 149/88 which was high for pt. 10 minutes later she felt no worse, but still felt "icky". This feeling lasted 75 minutes, after which pt returned to work. Pt had 12/30 off of work and felt fine until 12/31 when she had joint pain in her pelvis. Days 4 and 5 (1/1/21 and 1/2/21) she had ringing in her ears and BP as 105/56 (low for her). Symptoms now resolved.  1/26/2021: Pt received 2nd dose of COVID vaccine without issue.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Pelvic pain, Tinnitus
Clinical narrative: Moderna COVID-19 Vaccine EUA  After 1st dose of Moderna COVID vaccine. Per chart notes, pt tolerated well, had initial light headedness but BP WNL and pt felt normal after 20 minutes.  Per pt report 2 weeks later, pt heard rinigng in her ears w/in first 12 minutes and needed to lay down. BP was 149/88 which was high for pt. 10 minutes later she felt no worse, but still felt "icky". This feeling lasted 75 minutes, after which pt returned to work. Pt had 12/30 off of work and felt fine until 12/31 when she had joint pain in her pelvis. Days 4 and 5 (1/1/21 and 1/2/21) she had ringing in her ears and BP as 105/56 (low for her). Symptoms now resolved.  1/26/2021: Pt received 2nd dose of COVID vaccine without issue.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Blood test, Dizziness, Electrocardiogram, Heart rate increased
Clinical narrative: Pt presented with c/o throat feeling "thick" and dizziness. HR = 105, sat 97% Bp = 160/98. 25 mg Benadryl given. Within 3 minutes developed redness + swelling of neck, jaw + upper cheeks. Epipen given and additional 25 mg Benadryl. HR increased to 112. Lungs - CTA. Pt with h/o SVT. Taken to ED. No changes noted with Benadryl or Epi.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Pt presented with c/o throat feeling "thick" and dizziness. HR = 105, sat 97% Bp = 160/98. 25 mg Benadryl given. Within 3 minutes developed redness + swelling of neck, jaw + upper cheeks. Epipen given and additional 25 mg Benadryl. HR increased to 112. Lungs - CTA. Pt with h/o SVT. Taken to ED. No changes noted with Benadryl or Epi.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram abnormal, Erythema, Heart rate increased, Oropharyngeal discomfort
Clinical narrative: Pt presented with c/o throat feeling "thick" and dizziness. HR = 105, sat 97% Bp = 160/98. 25 mg Benadryl given. Within 3 minutes developed redness + swelling of neck, jaw + upper cheeks. Epipen given and additional 25 mg Benadryl. HR increased to 112. Lungs - CTA. Pt with h/o SVT. Taken to ED. No changes noted with Benadryl or Epi.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia, Swelling, Swelling face
Clinical narrative: Pt presented with c/o throat feeling "thick" and dizziness. HR = 105, sat 97% Bp = 160/98. 25 mg Benadryl given. Within 3 minutes developed redness + swelling of neck, jaw + upper cheeks. Epipen given and additional 25 mg Benadryl. HR increased to 112. Lungs - CTA. Pt with h/o SVT. Taken to ED. No changes noted with Benadryl or Epi.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death, Malaise, Pneumonia, Renal failure
Clinical narrative: Emergency Room HPI Patient is a 69 y.o. male who presents with complaint decreased responsiveness at the nursing home.  Patient not responding to painful stimulus as well as tactile or verbal stimulus.  Pupils 2 mm and nonreactive to light.  Patient was said to be active earlier today.  Patient is nonverbal and could not give any history.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Emergency Room HPI Patient is a 69 y.o. male who presents with complaint decreased responsiveness at the nursing home.  Patient not responding to painful stimulus as well as tactile or verbal stimulus.  Pupils 2 mm and nonreactive to light.  Patient was said to be active earlier today.  Patient is nonverbal and could not give any history.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Blood culture, Blood gases, Blood lactic acid, Brain natriuretic peptide
Clinical narrative: Emergency Room HPI Patient is a 69 y.o. male who presents with complaint decreased responsiveness at the nursing home.  Patient not responding to painful stimulus as well as tactile or verbal stimulus.  Pupils 2 mm and nonreactive to light.  Patient was said to be active earlier today.  Patient is nonverbal and could not give any history.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Computerised tomogram thorax, Culture urine, Differential white blood cell count
Clinical narrative: Emergency Room HPI Patient is a 69 y.o. male who presents with complaint decreased responsiveness at the nursing home.  Patient not responding to painful stimulus as well as tactile or verbal stimulus.  Pupils 2 mm and nonreactive to light.  Patient was said to be active earlier today.  Patient is nonverbal and could not give any history.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug screen, Electrocardiogram, Fibrin D dimer, Full blood count, Hypoaesthesia
Clinical narrative: Emergency Room HPI Patient is a 69 y.o. male who presents with complaint decreased responsiveness at the nursing home.  Patient not responding to painful stimulus as well as tactile or verbal stimulus.  Pupils 2 mm and nonreactive to light.  Patient was said to be active earlier today.  Patient is nonverbal and could not give any history.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Miosis, Pupillary reflex impaired, SARS-CoV-2 test, Troponin
Clinical narrative: Emergency Room HPI Patient is a 69 y.o. male who presents with complaint decreased responsiveness at the nursing home.  Patient not responding to painful stimulus as well as tactile or verbal stimulus.  Pupils 2 mm and nonreactive to light.  Patient was said to be active earlier today.  Patient is nonverbal and could not give any history.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli, Urine analysis
Clinical narrative: Emergency Room HPI Patient is a 69 y.o. male who presents with complaint decreased responsiveness at the nursing home.  Patient not responding to painful stimulus as well as tactile or verbal stimulus.  Pupils 2 mm and nonreactive to light.  Patient was said to be active earlier today.  Patient is nonverbal and could not give any history.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Facial paralysis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 12 hours after vaccine Bell's Palsey on Rt side Patient reported event when came to clinic for 2nd dose. Client went to clinic for evaluation states approx 12 hrs after vaccine.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: 12 hours after vaccine Bell's Palsey on Rt side Patient reported event when came to clinic for 2nd dose. Client went to clinic for evaluation states approx 12 hrs after vaccine.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: 12 hours after vaccine Bell's Palsey on Rt side Patient reported event when came to clinic for 2nd dose. Client went to clinic for evaluation states approx 12 hrs after vaccine.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Blood creatine, Blood magnesium, Chills
Clinical narrative: severe abdominal pain; This is a spontaneous report from a contactable consumer.   A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date. On an unspecified date within 48 hours after vaccination patient presented severe abdominal pain resulting in an hospital visit. At the time of the reporting event outcome was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Crying, Decreased appetite, Diarrhoea, Fatigue, Full blood count
Clinical narrative: severe abdominal pain; This is a spontaneous report from a contactable consumer.   A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date. On an unspecified date within 48 hours after vaccination patient presented severe abdominal pain resulting in an hospital visit. At the time of the reporting event outcome was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Glomerular filtration rate, Headache, Lipase, Metabolic function test
Clinical narrative: severe abdominal pain; This is a spontaneous report from a contactable consumer.   A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date. On an unspecified date within 48 hours after vaccination patient presented severe abdominal pain resulting in an hospital visit. At the time of the reporting event outcome was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain, Pregnancy test, Pyrexia
Clinical narrative: severe abdominal pain; This is a spontaneous report from a contactable consumer.   A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date. On an unspecified date within 48 hours after vaccination patient presented severe abdominal pain resulting in an hospital visit. At the time of the reporting event outcome was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound abdomen, Urine analysis
Clinical narrative: severe abdominal pain; This is a spontaneous report from a contactable consumer.   A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date. On an unspecified date within 48 hours after vaccination patient presented severe abdominal pain resulting in an hospital visit. At the time of the reporting event outcome was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain
Clinical narrative: severe abdominal pain; This is a spontaneous report from a contactable consumer.   A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date. On an unspecified date within 48 hours after vaccination patient presented severe abdominal pain resulting in an hospital visit. At the time of the reporting event outcome was unknown.  Information about Batch/Lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site mass, Rash, Rash pruritic
Clinical narrative: Rash redness lump in left arm, itchy. Stead next day to shoulder and elbow.  Took Tylenol and Benadryl followed by ibuprofen and Benadryl for 3 days.   Improved in 3 days  Mgmt suggested by my family practice doctor , sent by health portal with picture etc
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Nodule, Pruritus, Rash
Clinical narrative: Rash redness lump in left arm, itchy. Stead next day to shoulder and elbow.  Took Tylenol and Benadryl followed by ibuprofen and Benadryl for 3 days.   Improved in 3 days  Mgmt suggested by my family practice doctor , sent by health portal with picture etc
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Feeling hot, Joint range of motion decreased, Joint warmth
Clinical narrative: As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level.  Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis.  Father with Parkinson's disease.  I see that COVID-19 biofire came back positive.  In light of this, COVID myelopathy is on the differential
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level.  Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis.  Father with Parkinson's disease.  I see that COVID-19 biofire came back positive.  In light of this, COVID myelopathy is on the differential
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Gait disturbance, Hypoaesthesia, Limb discomfort, Myelopathy
Clinical narrative: As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level.  Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis.  Father with Parkinson's disease.  I see that COVID-19 biofire came back positive.  In light of this, COVID myelopathy is on the differential
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, SARS-CoV-2 test positive, Sensory loss
Clinical narrative: As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level.  Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis.  Father with Parkinson's disease.  I see that COVID-19 biofire came back positive.  In light of this, COVID myelopathy is on the differential
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: Developed diffuse pruritic rash 1 day after vaccination. Rash has persisted > 1 week. No associated shortness of breath, swelling of lips/tongue/ throat. No further symptoms. Rash improving with benadryl but not resolving.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Developed diffuse pruritic rash 1 day after vaccination. Rash has persisted > 1 week. No associated shortness of breath, swelling of lips/tongue/ throat. No further symptoms. Rash improving with benadryl but not resolving.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: Developed diffuse pruritic rash 1 day after vaccination. Rash has persisted > 1 week. No associated shortness of breath, swelling of lips/tongue/ throat. No further symptoms. Rash improving with benadryl but not resolving.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus, Rash, Rash vesicular
Clinical narrative: One hour after receiving the Covid-19 vaccine by Moderna patient became red and blotchy on her chest down to her stomach and around to the back.  Took Benadryl with no relief.  Prednisone for 1 week.  Rash localized on torso.  Rash blistered and popped, now has a burning sensation in area that had the rash.    Has some associated chills and sweats up until Wednesday.  They have not resolved.  No fever, nausea, vomiting or diarrhea.  No close contacts with the rash.  Has not eaten nuts or berries.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: One hour after receiving the Covid-19 vaccine by Moderna patient became red and blotchy on her chest down to her stomach and around to the back.  Took Benadryl with no relief.  Prednisone for 1 week.  Rash localized on torso.  Rash blistered and popped, now has a burning sensation in area that had the rash.    Has some associated chills and sweats up until Wednesday.  They have not resolved.  No fever, nausea, vomiting or diarrhea.  No close contacts with the rash.  Has not eaten nuts or berries.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister rupture, Burning sensation, Chills, Erythema, Hyperhidrosis
Clinical narrative: One hour after receiving the Covid-19 vaccine by Moderna patient became red and blotchy on her chest down to her stomach and around to the back.  Took Benadryl with no relief.  Prednisone for 1 week.  Rash localized on torso.  Rash blistered and popped, now has a burning sensation in area that had the rash.    Has some associated chills and sweats up until Wednesday.  They have not resolved.  No fever, nausea, vomiting or diarrhea.  No close contacts with the rash.  Has not eaten nuts or berries.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash macular, Rash papular, Rash vesicular
Clinical narrative: One hour after receiving the Covid-19 vaccine by Moderna patient became red and blotchy on her chest down to her stomach and around to the back.  Took Benadryl with no relief.  Prednisone for 1 week.  Rash localized on torso.  Rash blistered and popped, now has a burning sensation in area that had the rash.    Has some associated chills and sweats up until Wednesday.  They have not resolved.  No fever, nausea, vomiting or diarrhea.  No close contacts with the rash.  Has not eaten nuts or berries.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received Moderna vaccine outside of medical facility on 1/23/2021. Presented to medical facility on 2/21/2021 and received Pfizer vaccine.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: ~10 minutes after receiving second dose of Pfizer COVID vaccine while sitting in the waiting area, I started feeling light headed and I thought I was going to pass out.  Medical personnel in the waiting area came over, had me lay down and provided cold packs.  They stated this was likely a vasovagal like response.  When I have donated blood in the past I have had a very similar reaction.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: ~10 minutes after receiving second dose of Pfizer COVID vaccine while sitting in the waiting area, I started feeling light headed and I thought I was going to pass out.  Medical personnel in the waiting area came over, had me lay down and provided cold packs.  They stated this was likely a vasovagal like response.  When I have donated blood in the past I have had a very similar reaction.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased
Clinical narrative: Patient was given two doses of the vaccine on the same day.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Extra dose administered, Incorrect dose administered by device
Clinical narrative: Patient was given two doses of the vaccine on the same day.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Chest pain, Dyspnoea, Pharyngeal swelling, Vomiting
Clinical narrative: Anaphylaxis reaction --  Patient was brought to the ER.  2 IVs were placed.  She was initially given a dose of 125 mg of IV Solu-Medrol.  This was repeated.  She continued to have shortness of breath.  She was given multiple doses of subcutaneous epinephrine.  This did improve some of her shortness of breath for short period of time she was given another dose of 100 mg of IV Benadryl.  This did help with her throat swelling.  Unfortunately then she did get nauseated and tried to vomit.  Due to her throat swelling she was unable to do this.  We did give her 20 of IV Pepcid and 8 of IV Zofran.  During this time from the repeated doses of atropine (her heart rate was found to be in the 170s and 180s.  She did go through multiple runs of V. tach.  I did give her 10 mg of IV labetalol.  This did help slow her heart rate and rhythm without her blood pressure.  Her heart rate improved to less than 100.  Her blood pressure came down to normal.  As the labetalol continue to work her blood pressure did drop and she was found to be a little dizzy.  We did increase her IV fluids.  She continued to have some did give her 5 of Reglan and a 500 cc bolus due to hypotension.  I did spend 120 minutes in critical care time.  Her throat swelling had improved.  She was not have any chest pain and her shortness of breath had improved.  We will admitted to observation overnight.  Dr. will assume care 35 year old female presents to ED from clinic after 2nd dose covid vaccine.  Pt is experiencing an allergic reaction.  Pt has used one personal epi pen prior to arrival.  taken 200 mg oral benadryl that she vomited up and benadryl 100mg IM.  Pt flushed in neck area and has feeling of fullness in neck.  Mild epiglottis swelling noted.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Epiglottitis, Feeling abnormal
Clinical narrative: Anaphylaxis reaction --  Patient was brought to the ER.  2 IVs were placed.  She was initially given a dose of 125 mg of IV Solu-Medrol.  This was repeated.  She continued to have shortness of breath.  She was given multiple doses of subcutaneous epinephrine.  This did improve some of her shortness of breath for short period of time she was given another dose of 100 mg of IV Benadryl.  This did help with her throat swelling.  Unfortunately then she did get nauseated and tried to vomit.  Due to her throat swelling she was unable to do this.  We did give her 20 of IV Pepcid and 8 of IV Zofran.  During this time from the repeated doses of atropine (her heart rate was found to be in the 170s and 180s.  She did go through multiple runs of V. tach.  I did give her 10 mg of IV labetalol.  This did help slow her heart rate and rhythm without her blood pressure.  Her heart rate improved to less than 100.  Her blood pressure came down to normal.  As the labetalol continue to work her blood pressure did drop and she was found to be a little dizzy.  We did increase her IV fluids.  She continued to have some did give her 5 of Reglan and a 500 cc bolus due to hypotension.  I did spend 120 minutes in critical care time.  Her throat swelling had improved.  She was not have any chest pain and her shortness of breath had improved.  We will admitted to observation overnight.  Dr. will assume care 35 year old female presents to ED from clinic after 2nd dose covid vaccine.  Pt is experiencing an allergic reaction.  Pt has used one personal epi pen prior to arrival.  taken 200 mg oral benadryl that she vomited up and benadryl 100mg IM.  Pt flushed in neck area and has feeling of fullness in neck.  Mild epiglottis swelling noted.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Heart rate increased, Hypersensitivity, Nausea, Pharyngeal swelling
Clinical narrative: Anaphylaxis reaction --  Patient was brought to the ER.  2 IVs were placed.  She was initially given a dose of 125 mg of IV Solu-Medrol.  This was repeated.  She continued to have shortness of breath.  She was given multiple doses of subcutaneous epinephrine.  This did improve some of her shortness of breath for short period of time she was given another dose of 100 mg of IV Benadryl.  This did help with her throat swelling.  Unfortunately then she did get nauseated and tried to vomit.  Due to her throat swelling she was unable to do this.  We did give her 20 of IV Pepcid and 8 of IV Zofran.  During this time from the repeated doses of atropine (her heart rate was found to be in the 170s and 180s.  She did go through multiple runs of V. tach.  I did give her 10 mg of IV labetalol.  This did help slow her heart rate and rhythm without her blood pressure.  Her heart rate improved to less than 100.  Her blood pressure came down to normal.  As the labetalol continue to work her blood pressure did drop and she was found to be a little dizzy.  We did increase her IV fluids.  She continued to have some did give her 5 of Reglan and a 500 cc bolus due to hypotension.  I did spend 120 minutes in critical care time.  Her throat swelling had improved.  She was not have any chest pain and her shortness of breath had improved.  We will admitted to observation overnight.  Dr. will assume care 35 year old female presents to ED from clinic after 2nd dose covid vaccine.  Pt is experiencing an allergic reaction.  Pt has used one personal epi pen prior to arrival.  taken 200 mg oral benadryl that she vomited up and benadryl 100mg IM.  Pt flushed in neck area and has feeling of fullness in neck.  Mild epiglottis swelling noted.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Anaphylaxis reaction --  Patient was brought to the ER.  2 IVs were placed.  She was initially given a dose of 125 mg of IV Solu-Medrol.  This was repeated.  She continued to have shortness of breath.  She was given multiple doses of subcutaneous epinephrine.  This did improve some of her shortness of breath for short period of time she was given another dose of 100 mg of IV Benadryl.  This did help with her throat swelling.  Unfortunately then she did get nauseated and tried to vomit.  Due to her throat swelling she was unable to do this.  We did give her 20 of IV Pepcid and 8 of IV Zofran.  During this time from the repeated doses of atropine (her heart rate was found to be in the 170s and 180s.  She did go through multiple runs of V. tach.  I did give her 10 mg of IV labetalol.  This did help slow her heart rate and rhythm without her blood pressure.  Her heart rate improved to less than 100.  Her blood pressure came down to normal.  As the labetalol continue to work her blood pressure did drop and she was found to be a little dizzy.  We did increase her IV fluids.  She continued to have some did give her 5 of Reglan and a 500 cc bolus due to hypotension.  I did spend 120 minutes in critical care time.  Her throat swelling had improved.  She was not have any chest pain and her shortness of breath had improved.  We will admitted to observation overnight.  Dr. will assume care 35 year old female presents to ED from clinic after 2nd dose covid vaccine.  Pt is experiencing an allergic reaction.  Pt has used one personal epi pen prior to arrival.  taken 200 mg oral benadryl that she vomited up and benadryl 100mg IM.  Pt flushed in neck area and has feeling of fullness in neck.  Mild epiglottis swelling noted.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Metabolic function test, Nausea, Tryptase, Vomiting
Clinical narrative: After 12 hours of getting the first shot  I started to experince difficulty breathing, vomiting, coughing and fast heartbeat along with soar throat. I ended up to go the emergency room.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Heart rate increased, Oropharyngeal pain, Vomiting
Clinical narrative: After 12 hours of getting the first shot  I started to experince difficulty breathing, vomiting, coughing and fast heartbeat along with soar throat. I ended up to go the emergency room.
Age: 74.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pancreatitis necrotising
Clinical narrative: 74 YO M w h/o amebic liver abscess, pituitary tumor s/p resection  who had covid vaccine and 4 hours later had body aches, chills, lower abd pain and vomiting (x2). Denies fever, shortness of breath, facial swelling or anaphylaxis s/sx. Zofran was prescribed at the time of VAV. Pt was taken to ER and found to have severe acute pancreatitis (Lipase 5505) with possible necrosis with a lactate of 3.7. Received Vanco/Zosyn in ED. Recieved fluids and lactate improved to 2.9. Admitted to Tele. Pt had persistent hypotension refractory to IVF, NICOM nonresponsive, and AKI and was admitted to ICU for hypotension requiring pressors. Patient had septic shock. According to MD "Since this was his first shot, the abrupt timing of his presentation (4 hours after administration) is odd; also would not expect this degree of necrosis so early on as well. " Transferred out of ICU. Currently still inpatient and possible GI Bleed situation.
Age: 74.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Abdominal pain lower, Acute kidney injury, Blood lactic acid increased, Chills, Hypotension
Clinical narrative: 74 YO M w h/o amebic liver abscess, pituitary tumor s/p resection  who had covid vaccine and 4 hours later had body aches, chills, lower abd pain and vomiting (x2). Denies fever, shortness of breath, facial swelling or anaphylaxis s/sx. Zofran was prescribed at the time of VAV. Pt was taken to ER and found to have severe acute pancreatitis (Lipase 5505) with possible necrosis with a lactate of 3.7. Received Vanco/Zosyn in ED. Recieved fluids and lactate improved to 2.9. Admitted to Tele. Pt had persistent hypotension refractory to IVF, NICOM nonresponsive, and AKI and was admitted to ICU for hypotension requiring pressors. Patient had septic shock. According to MD "Since this was his first shot, the abrupt timing of his presentation (4 hours after administration) is odd; also would not expect this degree of necrosis so early on as well. " Transferred out of ICU. Currently still inpatient and possible GI Bleed situation.
Age: 74.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Intensive care, Lipase increased, Pain, Pancreatitis acute, Septic shock
Clinical narrative: 74 YO M w h/o amebic liver abscess, pituitary tumor s/p resection  who had covid vaccine and 4 hours later had body aches, chills, lower abd pain and vomiting (x2). Denies fever, shortness of breath, facial swelling or anaphylaxis s/sx. Zofran was prescribed at the time of VAV. Pt was taken to ER and found to have severe acute pancreatitis (Lipase 5505) with possible necrosis with a lactate of 3.7. Received Vanco/Zosyn in ED. Recieved fluids and lactate improved to 2.9. Admitted to Tele. Pt had persistent hypotension refractory to IVF, NICOM nonresponsive, and AKI and was admitted to ICU for hypotension requiring pressors. Patient had septic shock. According to MD "Since this was his first shot, the abrupt timing of his presentation (4 hours after administration) is odd; also would not expect this degree of necrosis so early on as well. " Transferred out of ICU. Currently still inpatient and possible GI Bleed situation.
Age: 74.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Vasopressive therapy, Vomiting
Clinical narrative: 74 YO M w h/o amebic liver abscess, pituitary tumor s/p resection  who had covid vaccine and 4 hours later had body aches, chills, lower abd pain and vomiting (x2). Denies fever, shortness of breath, facial swelling or anaphylaxis s/sx. Zofran was prescribed at the time of VAV. Pt was taken to ER and found to have severe acute pancreatitis (Lipase 5505) with possible necrosis with a lactate of 3.7. Received Vanco/Zosyn in ED. Recieved fluids and lactate improved to 2.9. Admitted to Tele. Pt had persistent hypotension refractory to IVF, NICOM nonresponsive, and AKI and was admitted to ICU for hypotension requiring pressors. Patient had septic shock. According to MD "Since this was his first shot, the abrupt timing of his presentation (4 hours after administration) is odd; also would not expect this degree of necrosis so early on as well. " Transferred out of ICU. Currently still inpatient and possible GI Bleed situation.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Patient had chest pain, dizziness, SOB, sensation of throat closing within 5 minutes of receiving the vaccine
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Throat tightness
Clinical narrative: Patient had chest pain, dizziness, SOB, sensation of throat closing within 5 minutes of receiving the vaccine
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash, Swelling
Clinical narrative: pt had redness, warmth, swelling around injection site starting 8-9 days after vaccine given
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: pt had redness, warmth, swelling around injection site starting 8-9 days after vaccine given
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Dyspnoea
Clinical narrative: Patient received 2nd dose of Moderna COVID-19 vaccine on 2/24/2021 around 1:30 PM at a drive through vaccination site. Around 3:45 PM patient developed sudden cough, congestion, and shortness of breath. She presented to our clinic around 4:29 PM and treatment included IM epinephrine 0.5ml, albuterol HFA 4 inhalations, Xyzal 5 mg tablet, and Breo 100mcg 1 inhalation in office. Symptoms greatly improved and patient was discharged in stable condition.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Nasal congestion
Clinical narrative: Patient received 2nd dose of Moderna COVID-19 vaccine on 2/24/2021 around 1:30 PM at a drive through vaccination site. Around 3:45 PM patient developed sudden cough, congestion, and shortness of breath. She presented to our clinic around 4:29 PM and treatment included IM epinephrine 0.5ml, albuterol HFA 4 inhalations, Xyzal 5 mg tablet, and Breo 100mcg 1 inhalation in office. Symptoms greatly improved and patient was discharged in stable condition.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Communication disorder, Contusion, Death, Thrombocytopenia
Clinical narrative: resident became lethargic and altered mental status, sent to hospital and swabbed covid positive (zero contact tracing) shot was given 88 days inside her covid recovery period.  once at hospital, developed Thrombocytpenia, was intubated and passed away 2/19/21
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: resident became lethargic and altered mental status, sent to hospital and swabbed covid positive (zero contact tracing) shot was given 88 days inside her covid recovery period.  once at hospital, developed Thrombocytpenia, was intubated and passed away 2/19/21
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Endotracheal intubation, Lethargy, Mental status changes
Clinical narrative: resident became lethargic and altered mental status, sent to hospital and swabbed covid positive (zero contact tracing) shot was given 88 days inside her covid recovery period.  once at hospital, developed Thrombocytpenia, was intubated and passed away 2/19/21
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Thrombocytopenia
Clinical narrative: resident became lethargic and altered mental status, sent to hospital and swabbed covid positive (zero contact tracing) shot was given 88 days inside her covid recovery period.  once at hospital, developed Thrombocytpenia, was intubated and passed away 2/19/21
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Injection site warmth
Clinical narrative: Pt found sitting upright with allergic reaction. Pt states she received the Moderna vaccine and started felling tingling down the arm that was vaccinated. Pt denies sob, - weakness, - dizziness, +warm/ itching sensation to chest. IV initiated and pt given Benadryl IVP. Pt is getting relief with Benadryl. Changes in patient condition en route. Care transferred to ED staff.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypersensitivity, Paraesthesia, Pruritus
Clinical narrative: Pt found sitting upright with allergic reaction. Pt states she received the Moderna vaccine and started felling tingling down the arm that was vaccinated. Pt denies sob, - weakness, - dizziness, +warm/ itching sensation to chest. IV initiated and pt given Benadryl IVP. Pt is getting relief with Benadryl. Changes in patient condition en route. Care transferred to ED staff.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Ill-defined disorder, Skin lesion
Clinical narrative: Consumer reported developing 5-8 lesions following VARlVAX administration.; This spontaneous report was received from a nurse practitioner, referring to a 7-year-old female patient. The patient had no pertinent medical history, previous drug reactions, allergies, or concomitant medications.   On 28-JAN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliter (ml) by subcutaneous route (lot number T022315 which has been verified to be valid, expiration date reported as 30-JAN-2022, but upon internal validation established as 30-JUN-2022) (vaccination scheme and anatomical site of injection were not reported) as immunisation. Sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) was reported, however, no information was given regarding the use of it.   On 28-JAN-2021, following the administration of varicella virus vaccine live (Oka/Merck) (VARIVAX), the patient developed 5-8 lesions (ill-defined disorder). The patient sought medical attention, however, no treatment was given for the event. In addition, no laboratory diagnostic studies were performed.   The outcome of the event ill-defined disorder was unknown by the reporter. The causality assessment between the aforementioned event and therapy with varicella virus vaccine live (Oka/Merck) (VARIVAX), was not provided.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took one unrefrigerated dose of Vivotif; Spontaneous report received on 10FEB2020.  A pharmacist reported that a female consumer who "took one unrefrigerated dose of Vivotif" (PT: Product storage error). The consumer was receiving Vivotif capsule for immunisation. On 04FEB2020, the consumer took the first dose of Vivotif which was refrigerated. She left the second dose unrefrigerated (left out at room temperature for over 24 hours), and took the unrefrigerated dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took second dose of Vivotif which was unrefrigerated (product storage error). The second dose of Vivotif was left out at the room temperature for over 24 hours. Vivotif must stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is not applicable to Vivotif.; Sender's Comments: A consumer took second dose of Vivotif which was unrefrigerated (product storage error). The second dose of Vivotif was left out at the room temperature for over 24 hours. Vivotif must stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is not applicable to Vivotif.
Age: 11.0
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took unrefrigerated doses of Vivotif; Spontaneous report received on 10FEB2020.  A pharmacist reported that a consumer "took unrefrigerated doses of Vivotif" (PT: Product storage error) while being on Vivotif for immunisation. On 02FEB2020, the consumer took the first refrigerated dose of Vivotif. The consumer took the remaining three doses of Vivotif which were unrefrigerated. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took three doses of Vivotif which were unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took three doses of Vivotif which were unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Age: 23.0
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had eaten a full meal 40 minutes before and cookies 30 minutes after taking first dose of Vivotif; Spontaneous report received on 14FEB2020.  A healthcare professional reported that a consumer "had eaten a full meal 40 minutes before and cookies 30 minutes after taking first dose of Vivotif" (PT: Product administration error). The consumer was receiving Vivotif for immunisation. On 13FEB2020, the consumer ate a full meal then took the first dose of Vivotif 40 minutes later and then ate a couple of cookies 30 minutes after that same dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer had eaten a meal 40 minutes before taking first dose of Vivotif and also ate cookies 30 minutes after taking Vivotif first dose (product administration error). Vivotif should be taken one hour before a meal and consumer should eat or drink for at least an hour both before and after taking Vivotif dose. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer had eaten a meal 40 minutes before taking first dose of Vivotif and also ate cookies 30 minutes after taking Vivotif first dose (product administration error). Vivotif should be taken one hour before a meal and consumer should eat or drink for at least an hour both before and after taking Vivotif dose. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.