chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Feeling cold, Grip strength decreased
Clinical narrative: Thursday night shortly after the vaccine I was exhausted and headed home to go lay down. While driving, I developed a severe headache. I went home and went to sleep really early. Friday morning, woke up, went to work. Extreme lethargy and severe headache. Left work early (2 ish) with joint pain, headache, lethargy. In the evening (still Friday) I went to the grocery store and walking in the parking lot to the store my joints hurt with every step. I sent my partner in and I went back to the car. I could not do it. Went to sleep soon thereafter. Saturday morning, we woke up and had planned to go to the cabin. We were trying to run errands (coffee shop, post office, bank...simple errands) and I was exhausted and feeling bad. Still headache, lethargy, achy. Assumed it was flu like which was a side effect, so I continued to press on through the discomfort. Left for the mountains. less than 1 mile from home, started to feel tingling and "buzzing" throughout my body, like a vibration sort of. Stayed quiet and thought about this. Another block or two and the feeling was in my tongue. Then I felt it in each tooth root and spoke up. I asked to go home and rest for 30 minutes before going to the cabin. At this point, I could not move my hands. We got to the house and I could not open my car door or take off my seatbelt. I had hand paralysis for about 10 minutes. Made it in the house. Got to the couch and laid down for about 60 seconds. Got up had to use the restroom. Solid, not diarrhea, but took 45 minutes. Apparently, I was pale like a piece of paper. I do not remember being in the bathroom for 45 minutes, I felt like it was 5 minutes, partner said 45 minutes. Made it back to couch, laid down, freezing! Under 2 blankets, one of them was an electric blanket on high. Began throwing up, clear bile. Had not eaten anything yet. Stayed on couch, also lost track of time, was there for 5 ish hours. Tried to eat something so I could take Tylenol for the headache. Barely ate anything, so I never took the Tylenol. It lessened. Cabin trip cancelled. Still lethargy and dizzy yesterday but no joint pain, no nausea. Now, Monday morning, still dizzy/lightheaded. Symptoms are subsiding, but not gone.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Lethargy, Mobility decreased, Monoplegia
Clinical narrative: Thursday night shortly after the vaccine I was exhausted and headed home to go lay down. While driving, I developed a severe headache. I went home and went to sleep really early. Friday morning, woke up, went to work. Extreme lethargy and severe headache. Left work early (2 ish) with joint pain, headache, lethargy. In the evening (still Friday) I went to the grocery store and walking in the parking lot to the store my joints hurt with every step. I sent my partner in and I went back to the car. I could not do it. Went to sleep soon thereafter. Saturday morning, we woke up and had planned to go to the cabin. We were trying to run errands (coffee shop, post office, bank...simple errands) and I was exhausted and feeling bad. Still headache, lethargy, achy. Assumed it was flu like which was a side effect, so I continued to press on through the discomfort. Left for the mountains. less than 1 mile from home, started to feel tingling and "buzzing" throughout my body, like a vibration sort of. Stayed quiet and thought about this. Another block or two and the feeling was in my tongue. Then I felt it in each tooth root and spoke up. I asked to go home and rest for 30 minutes before going to the cabin. At this point, I could not move my hands. We got to the house and I could not open my car door or take off my seatbelt. I had hand paralysis for about 10 minutes. Made it in the house. Got to the couch and laid down for about 60 seconds. Got up had to use the restroom. Solid, not diarrhea, but took 45 minutes. Apparently, I was pale like a piece of paper. I do not remember being in the bathroom for 45 minutes, I felt like it was 5 minutes, partner said 45 minutes. Made it back to couch, laid down, freezing! Under 2 blankets, one of them was an electric blanket on high. Began throwing up, clear bile. Had not eaten anything yet. Stayed on couch, also lost track of time, was there for 5 ish hours. Tried to eat something so I could take Tylenol for the headache. Barely ate anything, so I never took the Tylenol. It lessened. Cabin trip cancelled. Still lethargy and dizzy yesterday but no joint pain, no nausea. Now, Monday morning, still dizzy/lightheaded. Symptoms are subsiding, but not gone.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pallor, Paraesthesia, Paraesthesia oral, Time perception altered
Clinical narrative: Thursday night shortly after the vaccine I was exhausted and headed home to go lay down. While driving, I developed a severe headache. I went home and went to sleep really early. Friday morning, woke up, went to work. Extreme lethargy and severe headache. Left work early (2 ish) with joint pain, headache, lethargy. In the evening (still Friday) I went to the grocery store and walking in the parking lot to the store my joints hurt with every step. I sent my partner in and I went back to the car. I could not do it. Went to sleep soon thereafter. Saturday morning, we woke up and had planned to go to the cabin. We were trying to run errands (coffee shop, post office, bank...simple errands) and I was exhausted and feeling bad. Still headache, lethargy, achy. Assumed it was flu like which was a side effect, so I continued to press on through the discomfort. Left for the mountains. less than 1 mile from home, started to feel tingling and "buzzing" throughout my body, like a vibration sort of. Stayed quiet and thought about this. Another block or two and the feeling was in my tongue. Then I felt it in each tooth root and spoke up. I asked to go home and rest for 30 minutes before going to the cabin. At this point, I could not move my hands. We got to the house and I could not open my car door or take off my seatbelt. I had hand paralysis for about 10 minutes. Made it in the house. Got to the couch and laid down for about 60 seconds. Got up had to use the restroom. Solid, not diarrhea, but took 45 minutes. Apparently, I was pale like a piece of paper. I do not remember being in the bathroom for 45 minutes, I felt like it was 5 minutes, partner said 45 minutes. Made it back to couch, laid down, freezing! Under 2 blankets, one of them was an electric blanket on high. Began throwing up, clear bile. Had not eaten anything yet. Stayed on couch, also lost track of time, was there for 5 ish hours. Tried to eat something so I could take Tylenol for the headache. Barely ate anything, so I never took the Tylenol. It lessened. Cabin trip cancelled. Still lethargy and dizzy yesterday but no joint pain, no nausea. Now, Monday morning, still dizzy/lightheaded. Symptoms are subsiding, but not gone.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vibratory sense increased, Vomiting
Clinical narrative: Thursday night shortly after the vaccine I was exhausted and headed home to go lay down. While driving, I developed a severe headache. I went home and went to sleep really early. Friday morning, woke up, went to work. Extreme lethargy and severe headache. Left work early (2 ish) with joint pain, headache, lethargy. In the evening (still Friday) I went to the grocery store and walking in the parking lot to the store my joints hurt with every step. I sent my partner in and I went back to the car. I could not do it. Went to sleep soon thereafter. Saturday morning, we woke up and had planned to go to the cabin. We were trying to run errands (coffee shop, post office, bank...simple errands) and I was exhausted and feeling bad. Still headache, lethargy, achy. Assumed it was flu like which was a side effect, so I continued to press on through the discomfort. Left for the mountains. less than 1 mile from home, started to feel tingling and "buzzing" throughout my body, like a vibration sort of. Stayed quiet and thought about this. Another block or two and the feeling was in my tongue. Then I felt it in each tooth root and spoke up. I asked to go home and rest for 30 minutes before going to the cabin. At this point, I could not move my hands. We got to the house and I could not open my car door or take off my seatbelt. I had hand paralysis for about 10 minutes. Made it in the house. Got to the couch and laid down for about 60 seconds. Got up had to use the restroom. Solid, not diarrhea, but took 45 minutes. Apparently, I was pale like a piece of paper. I do not remember being in the bathroom for 45 minutes, I felt like it was 5 minutes, partner said 45 minutes. Made it back to couch, laid down, freezing! Under 2 blankets, one of them was an electric blanket on high. Began throwing up, clear bile. Had not eaten anything yet. Stayed on couch, also lost track of time, was there for 5 ish hours. Tried to eat something so I could take Tylenol for the headache. Barely ate anything, so I never took the Tylenol. It lessened. Cabin trip cancelled. Still lethargy and dizzy yesterday but no joint pain, no nausea. Now, Monday morning, still dizzy/lightheaded. Symptoms are subsiding, but not gone.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Myalgia, Pyrexia
Clinical narrative: fever, chills, muscle ache, headache. called in sick to work.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash macular
Clinical narrative: red, blotchy rash. Given 50 mg Benadryl po
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: red, blotchy rash. Given 50 mg Benadryl po
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Waited 15 mins at the place that received shot and left at 11:28am and when got to Department to work shortly after started to itch and got a small rash on the right wrist- nose did itch also. Went to lunch and didn't get better so went to Employ Health but they didn't have Benadryl so back to place the shot was given and was given Benadryl and had me wait 15 minutes to make sure ok. Went to the Pharmacy to get Benadryl for home incase I needed it tonight. Nurse from Employ Health Volte me to make sure I was ok.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Waited 15 mins at the place that received shot and left at 11:28am and when got to Department to work shortly after started to itch and got a small rash on the right wrist- nose did itch also. Went to lunch and didn't get better so went to Employ Health but they didn't have Benadryl so back to place the shot was given and was given Benadryl and had me wait 15 minutes to make sure ok. Went to the Pharmacy to get Benadryl for home incase I needed it tonight. Nurse from Employ Health Volte me to make sure I was ok.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: a red circle where I got the vaccine, it is still a firm nodule, itches lightly and is slightly warm (although I may just have warm skin in this office).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Pruritus
Clinical narrative: Caregiver was in the observation room for her 30 minutes but two minutes (11:29am) after her stay, she developed itching on her back,  redness on her chest and a burning feeling in her chest. At 11:33 she also c/o itching of the scalp.  BP:  139/69, HR: 99, RR: 16 and Sao2: 100% on room air.  Caregiver stated her itching was getting worse.  At 11:35 caregiver given 60mg of Fexofenadine PO per protocol for itching in back and head.  At 11:40, caregiver states neck was itching as well but no swelling, difficulty breathing or shortness of breath.  AT 11:54 BP: 117/48, HR:75, RR: 14 Sao2: 100% on room air.  When using a scale system to rate itchiness, caregiver states itching in back is 4/10, neck is 4/10,  head is 5/10 and chest burning rated 4/10.  At 12:10, caregiver states the itching in her back and neck was gone rated 0/10.  She also states chest burning was gone rated 0/10 and only had slight itchy feeling in head  rated 1/10.  At 12:20 the itching was resolved.  BP: 119/47, HR: 70, RR: 14, Sao2: 100% on room air.  Caregiver states she feels "back to normal."  Caregiver allowed to leave observation area.  Gait steady.  No complaints voiced.  Occupational Health manager aware of situation and involved in treatment plan.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever 100.3 Body aches Head aches Nausea  Treatment: Naproxen and Tylenol
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: HA, fatigue, low grade fever, body aches treatment include Tylenol with improvement.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Aspiration pleural cavity, Cough, Oral pruritus, Pruritus, Throat clearing
Clinical narrative: Dose administered @ 9:30 am, at 1 PM began with throat clearing and coughing with mild tightness, intermittently. By 1:30-1:45 pm nose and mouth became itchy.  I took 12.5 mg Benadryl and used my Xopenex ( rescue inhaler) x 2 puffs with effect.  Itching resolved first and residual inflammation in airway was gone by 3-3:30 pm. This reaction is familiar to me from when I received Allergy Immunotherapy a few years ago. I had my Epipen  and additional Benadryl. Did not need it.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine was incorrectly reconstituted with 0.8mL NS instead of 1.8mL by LPN. After incorrect reconstitution, 0.3mL of the vaccine solution was administered IM. Patient stayed in office for 15 minutes after administration. During that time, no adverse effects were reported by patient or noted by healthcare providers.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram thorax, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Elevated heart rate to 120, fever, shortness of breath, headache
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pyrexia
Clinical narrative: Elevated heart rate to 120, fever, shortness of breath, headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Laboratory test, Presyncope
Clinical narrative: extreme fatigue with, headache. Went to ER And Received fluids And meds for headache. SEEN IN E.D 1/7 & 12/19 (after both 1st & 2nd vaccine) ZOFRAN & FLUIDS IN E.D. DIAGNOSIS "NEAR SYNCOPE"
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain in extremity, Respiratory tract congestion
Clinical narrative: Arm was very sore for 4 days after vaccination.  Have never had a sore arm from vaccinations in the past. At day 4 post vaccination, developed a cough and congestion -- had none previously.  Now on day 9 post vaccination and it is tapering down.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash, hot to touch, appeared around injection site, around 3 inches in diameter, 12 days after receiving injection. Rash increased in size the following day but had less clearly defined borders. Rash began to resolve within 24 hours after taking antihistamine.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria-starting at 0645 1/11/2021
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle soreness, diarrhea, fatigue
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Musculoskeletal stiffness, Oxygen saturation decreased, Peripheral coldness, Presyncope
Clinical narrative: Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse absent, Respiratory rate increased, Seizure like phenomena, Skin discolouration, Skin warm
Clinical narrative: Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Unresponsive to stimuli
Clinical narrative: Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Oropharyngeal discomfort, Pharyngeal paraesthesia
Clinical narrative: Due to clients extensive history of allergies, client was placed in 30 minutes post vaccine observation by EMS.  It was there client started experiencing " tingling and scratchy throat." Client's VS were taken at 1148 and as follows: BP 144/103, Pulse 85, O2 Sat 100%-EMS took over care and continued to monitor patient.  At 1159 BP has increased to 158/95. At 1200  50 mg Benadryl IM was given in RDM.  At 1204 BP had decreased to 148/86. EMS made the call to transport the client to Hospital for further evaluation and treatment.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Urticaria
Clinical narrative: 10X7 cm, red patchy colored area on left arm at injection site warm to the touch. hive like appearance. Began 2-3 days after IZ administration. symptoms are reducing at this time.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: 10X7 cm, red patchy colored area on left arm at injection site warm to the touch. hive like appearance. Began 2-3 days after IZ administration. symptoms are reducing at this time.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Urticaria
Clinical narrative: Returned to office on 1/11/2021. Local reaction to Left upper arm . Reddened, Warm to touch10x7 cm.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Returned to office on 1/11/2021. Local reaction to Left upper arm . Reddened, Warm to touch10x7 cm.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Pt. noticed on Sunday ( 11 days post vaccine) a rash at vaccine site. Not warm to touch, not itchy and swelling.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Pt. noticed on Sunday ( 11 days post vaccine) a rash at vaccine site. Not warm to touch, not itchy and swelling.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash on Right arm 11 days post vaccine. No itchy, swelling, or redness.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on Right arm 11 days post vaccine. No itchy, swelling, or redness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Dizziness, Dyspnoea, Endotracheal intubation, Flushing
Clinical narrative: 38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immediately after receiving the vaccine, patient developed lightheadedness, flushing, hives, wheezing and throat swelling.  Patient was treated in an emergency department with epinephrine, gradually improved and was able to be sent home with an EpiPen, prednisone, hydroxyzine, and famotidine.  The next day, patient again developed shortness of breath and her husband administered the EpiPen.  EMS arrived and gave another dose of IM epinephrine and IV diphenhydramine.  On arrival to the emergency department, the patient was altered, diaphoretic, tachypneic, tachycardic, and stridulous.  Patient was given multiple doses of IM epinephrine and started on epinephrine drip.  Stridor continued and was unresponsive to nebulized albuterol.  Patient was then intubated and placed on mechanical ventilation.  Other treatments included solumedrol, pepcid, magnesium sulfate, nebulized epinephrine, and IV fluids.  admitted to the intensive care unit, weaned off epinephrine drip, and extubated the next day.  Patient was monitored on hospital floor for one additional day and was then discharged with no residual symptoms.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Intensive care, Mechanical ventilation, Pharyngeal swelling
Clinical narrative: 38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immediately after receiving the vaccine, patient developed lightheadedness, flushing, hives, wheezing and throat swelling.  Patient was treated in an emergency department with epinephrine, gradually improved and was able to be sent home with an EpiPen, prednisone, hydroxyzine, and famotidine.  The next day, patient again developed shortness of breath and her husband administered the EpiPen.  EMS arrived and gave another dose of IM epinephrine and IV diphenhydramine.  On arrival to the emergency department, the patient was altered, diaphoretic, tachypneic, tachycardic, and stridulous.  Patient was given multiple doses of IM epinephrine and started on epinephrine drip.  Stridor continued and was unresponsive to nebulized albuterol.  Patient was then intubated and placed on mechanical ventilation.  Other treatments included solumedrol, pepcid, magnesium sulfate, nebulized epinephrine, and IV fluids.  admitted to the intensive care unit, weaned off epinephrine drip, and extubated the next day.  Patient was monitored on hospital floor for one additional day and was then discharged with no residual symptoms.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Stridor, Tachycardia, Tachypnoea, Urticaria, Wheezing
Clinical narrative: 38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immediately after receiving the vaccine, patient developed lightheadedness, flushing, hives, wheezing and throat swelling.  Patient was treated in an emergency department with epinephrine, gradually improved and was able to be sent home with an EpiPen, prednisone, hydroxyzine, and famotidine.  The next day, patient again developed shortness of breath and her husband administered the EpiPen.  EMS arrived and gave another dose of IM epinephrine and IV diphenhydramine.  On arrival to the emergency department, the patient was altered, diaphoretic, tachypneic, tachycardic, and stridulous.  Patient was given multiple doses of IM epinephrine and started on epinephrine drip.  Stridor continued and was unresponsive to nebulized albuterol.  Patient was then intubated and placed on mechanical ventilation.  Other treatments included solumedrol, pepcid, magnesium sulfate, nebulized epinephrine, and IV fluids.  admitted to the intensive care unit, weaned off epinephrine drip, and extubated the next day.  Patient was monitored on hospital floor for one additional day and was then discharged with no residual symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Eye swelling, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: 01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vaccine 01/09 body aches, headache couldn?t move neck due to stiffness; 01/10 left arm soreness, armpit pulsation, fever range 102 F,; 01/11 vomiting. seasonal allergy eye drops for right eye swelling (went away), Benadryl 50 mg.; ibuprofen and Tylenol around the clock starting 01/09 to present day, 01/11/2021
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Seasonal allergy, Vomiting
Clinical narrative: 01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vaccine 01/09 body aches, headache couldn?t move neck due to stiffness; 01/10 left arm soreness, armpit pulsation, fever range 102 F,; 01/11 vomiting. seasonal allergy eye drops for right eye swelling (went away), Benadryl 50 mg.; ibuprofen and Tylenol around the clock starting 01/09 to present day, 01/11/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient reported soreness/painful up into clavicle area of right side where injection occurred. Patient also reports swollen and painful lymph nodes on right side where injection occurred.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia
Clinical narrative: 1 day after vaccination I experienced muscle pain, weakness, and chills. Symptoms lasted for roughly 1 day.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Nausea, Pain, Pyrexia
Clinical narrative: soreness in chest fever chills slight nausea body aches
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Employee felt dizzy and lightheaded. Stated she "felt like she was going to pass out." Gave her orange juice placed her in Exam room lying down took B/P, O2 and Kept Eye on her. Dr. examined her and had her stay lying down for at least 30 mins. Employee was feeling much better and left at 4:00pm with someone to drive her home.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hyperventilation, Hypoaesthesia, Nasal congestion
Clinical narrative: Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer).  Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions.  Given diphenhydramine, famotidine, and prednisone in emergency department.  During observation in ED, started having throat and chest tightness with hyperventilation.  This improved with lorazepam.  Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer).  Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions.  Given diphenhydramine, famotidine, and prednisone in emergency department.  During observation in ED, started having throat and chest tightness with hyperventilation.  This improved with lorazepam.  Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Noticed hives shortly after 1 woke up on 1/9/21. ~10am. Hives were white and all over legs and on back of my arms. Also had temp of 99.3..could be due to hives. Took benedryl and symptoms subsided 1/9/21 in the evening.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Muscular weakness
Clinical narrative: Pt received 1st dose on 7/1/20 at pharmacy-received 2nd dose on 8/31/20 MSO at Pharmacy. Pt reported complete arm muscle weakness, numbness - decreased range of motion. After 2nd dose pt could hardly move arm
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral, Hemiparesis, Neurological symptom
Clinical narrative: PATIENT PRESENTED TO ER ON 1/8/21 @ 6AM WITH STROKE SYMPTOMS INCLUDING (R) SIDE WEAKNESS
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Condition aggravated, Facial paralysis, Hemiparesis, Rash erythematous
Clinical narrative: Patient had a rash prior to COVID vaccine. Prednisone 10mg started on 1/5/21 (only one dose administered) 1/6/21, 1am - Rash worsened with increase redness, warmth and extending of body surface, Temp 100.4, 1/6/21, 1:20am Benadryl 25mg administered, (Keflex was ordered at this time, however never administered). 1/6/21, 3am rash improved, temp 99.1 1/6/21, 6:50am Right facial droop and right sided weakness, sent to ER 1/6/21 transferred to hospital, continues to be hospitalized 1/11/2021
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Skin warm
Clinical narrative: Patient had a rash prior to COVID vaccine. Prednisone 10mg started on 1/5/21 (only one dose administered) 1/6/21, 1am - Rash worsened with increase redness, warmth and extending of body surface, Temp 100.4, 1/6/21, 1:20am Benadryl 25mg administered, (Keflex was ordered at this time, however never administered). 1/6/21, 3am rash improved, temp 99.1 1/6/21, 6:50am Right facial droop and right sided weakness, sent to ER 1/6/21 transferred to hospital, continues to be hospitalized 1/11/2021
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Head ache started at 10:20am took Tylenol. At 12:15 i still have a headache.  If head ache continues i will take more medications.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: patient did not have any type of reaction; freezer went out of range after being checked on 11/19/2020; This spontaneous report was received from a nurse and refers to a 4 year old female patient. There was no information about the patient's concomitant therapies or medical history provided. The patient's concurrent condition included congenital metatarsus adductus (reported as Q66.22).  On 19-NOV-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot # T013540 and expiration date 17-OCT-2021) subcutaneously in the left thigh (LT) and diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL) (lot # C5656AA and expiration date 13-AUG-2021 ) intramuscularly in the right thigh (RT) for prophylaxis. It was reported, that on that day the freezer went out of range and wasn't checked again until the afternoon of 20-NOV-2020. The manufacturer was notified and all vaccines were labeled with an excursion sticker. The patient's mother was notified of the event and she was understanding. The patient did not have any type of reaction. A data logger was used to capture that temperature excursion, but no further details regarding the temperatures were available.; Sender's Comments:  US-009507513-2011USA013282:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Myalgia
Clinical narrative: 24 hours of chills, myalgia, headache, fatigue. Max temp 99.6
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Decreased appetite, Diarrhoea, Gait inability
Clinical narrative: HPI narrative: Patient was fine until 2 days ago.  Patient does have chronic dementia but got Covid vaccine 11:00 2 days ago and that night seem to be confused and not able to walk since then. Patient poor appetite since yesterday.  Patient had diarrhea 3 x 2 days ago.  No vomiting no fever no cough does not appear to be short of breath.  Patient also with left hip pain for few days with no injury.All history obtained from caretaker at bedside.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiratory tract congestion
Clinical narrative: body aches, congestion
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Hypoaesthesia, Rash, Rash erythematous
Clinical narrative: Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient.  A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization.  Medical history included hypothyroidism and chronic low back pain.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness.  She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Skin warm, Urticaria
Clinical narrative: Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient.  A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization.  Medical history included hypothyroidism and chronic low back pain.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness.  She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: fever of 100.9, swollen lymph nodes, body aches, joint pain
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Illness, Rectal haemorrhage
Clinical narrative: Rectal bleeding; Stomach ache; Diarrhea; sick; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect.  A 41-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right arm on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 01Jan2021, the patient experienced: rectal bleeding, stomachache, diarrhea, sick; all assessed as medically significant. The clinical course was reported as follows: The patient received the first dose of the COVID-19 vaccine on 20Dec2020; as she was at high risk due to working with COVID patients in the hospital. The patient became sick on 01Jan2021. The patient experienced a stomach-ache, diarrhea, and rectal bleeding. When these events occurred, the patient went to the emergency room (ER). A doctor there prescribed the patient the antibiotics metronidazole 500 mg and cefdinir 300 mg. The patient was also scheduled to follow up with a gastrointestinal (GI) doctor. The patient called asking if she should get the second dose since she was taking antibiotics. The patient was scheduled for the second dose on 08Jan2020.The patient reported she had improved. The symptoms, at the time of the report, were not that bad. Therapeutic measures were taken as a result of rectal bleeding, stomachache, diarrhea, and sick. The clinical outcome of the events was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Limb discomfort
Clinical narrative: HEAVY WARMTH FEELING IN EXTREAMITIES
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Condition aggravated, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine.  No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Impaired work ability
Clinical narrative: Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine.  No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injected limb mobility decreased, Injection site joint pain, Injection site pain
Clinical narrative: eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1685) intramuscular at arm left, on 19Dec2020 06:45 at single dose for covid-19 immunisation. Medical history included ongoing acne. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included isotretinoin (ACCUTANE). On 19Dec2020 11:30, approximate 5 hours after vaccine, the patient experienced pain, joint pain and tenderness at injection site, progressively loss of strength and eventually inability to move arm. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was recovered.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Gait disturbance, Headache, Nausea
Clinical narrative: Dizzy, Headache, unsteady on feet, chest feels heavy, nauseated