chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Cold sweat, Diarrhoea, Dizziness
Clinical narrative: mild abdominal cramp; an episode of loose stools; profuse sweating; lightheadedness; headache; severe weakness; entire body felt cool and clammy; entire body felt cool and clammy; This is a spontaneous report from a contactable physician (patient himself). A 34-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection; batch/lot number: ek5730), intramuscularly on the left arm on 15Dec2020 at 19:30 at a single dose for immunization at the hospital facility. Relevant medical history included childhood asthma and attention deficit hyperactivity disorder (ADD). Concomitant medication included lisdexamfetamine mesilate (VYVANSE) from an unspecified date in Dec2020. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Roughly 13 hours after the vaccine administration, on 16Dec2020 at 08:00, the patient had mild abdominal cramp. He went to have a bowel movement and had an episode of loose stools. Within seconds after that, he started experiencing profuse sweating, lightheadedness, headache, severe weakness and his entire body felt cool and clammy. He managed to drink some water and laid down on the floor for the next few minutes. The episode lasted for a few minutes. All the events occurred on 16Dec2020 at 08:00 AM. The patient was not hospitalized for the events. Therapeutic measures were taken as a result of mild abdominal cramp, an episode of loose stools, profuse sweating, lightheadedness, headache, severe weakness, and entire body felt cool and clammy, which included acetaminophen (TYLENOL) 1000 mg. The patient recovered from the events "mild abdominal cramp, an episode of loose stools, profuse sweating, lightheadedness, headache, severe weakness, and entire body felt cool and clammy on an unspecified date in Dec2020.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Hyperhidrosis
Clinical narrative: mild abdominal cramp; an episode of loose stools; profuse sweating; lightheadedness; headache; severe weakness; entire body felt cool and clammy; entire body felt cool and clammy; This is a spontaneous report from a contactable physician (patient himself). A 34-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection; batch/lot number: ek5730), intramuscularly on the left arm on 15Dec2020 at 19:30 at a single dose for immunization at the hospital facility. Relevant medical history included childhood asthma and attention deficit hyperactivity disorder (ADD). Concomitant medication included lisdexamfetamine mesilate (VYVANSE) from an unspecified date in Dec2020. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Roughly 13 hours after the vaccine administration, on 16Dec2020 at 08:00, the patient had mild abdominal cramp. He went to have a bowel movement and had an episode of loose stools. Within seconds after that, he started experiencing profuse sweating, lightheadedness, headache, severe weakness and his entire body felt cool and clammy. He managed to drink some water and laid down on the floor for the next few minutes. The episode lasted for a few minutes. All the events occurred on 16Dec2020 at 08:00 AM. The patient was not hospitalized for the events. Therapeutic measures were taken as a result of mild abdominal cramp, an episode of loose stools, profuse sweating, lightheadedness, headache, severe weakness, and entire body felt cool and clammy, which included acetaminophen (TYLENOL) 1000 mg. The patient recovered from the events "mild abdominal cramp, an episode of loose stools, profuse sweating, lightheadedness, headache, severe weakness, and entire body felt cool and clammy on an unspecified date in Dec2020.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Headache, Hyperhidrosis
Clinical narrative: mild abdominal cramp; an episode of loose stools; profuse sweating; lightheadedness; headache; severe weakness; entire body felt cool and clammy; entire body felt cool and clammy; This is a spontaneous report from a contactable physician (patient himself). A 34-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection; batch/lot number: ek5730), intramuscularly on the left arm on 15Dec2020 at 19:30 at a single dose for immunization at the hospital facility. Relevant medical history included childhood asthma and attention deficit hyperactivity disorder (ADD). Concomitant medication included lisdexamfetamine mesilate (VYVANSE) from an unspecified date in Dec2020. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Roughly 13 hours after the vaccine administration, on 16Dec2020 at 08:00, the patient had mild abdominal cramp. He went to have a bowel movement and had an episode of loose stools. Within seconds after that, he started experiencing profuse sweating, lightheadedness, headache, severe weakness and his entire body felt cool and clammy. He managed to drink some water and laid down on the floor for the next few minutes. The episode lasted for a few minutes. All the events occurred on 16Dec2020 at 08:00 AM. The patient was not hospitalized for the events. Therapeutic measures were taken as a result of mild abdominal cramp, an episode of loose stools, profuse sweating, lightheadedness, headache, severe weakness, and entire body felt cool and clammy, which included acetaminophen (TYLENOL) 1000 mg. The patient recovered from the events "mild abdominal cramp, an episode of loose stools, profuse sweating, lightheadedness, headache, severe weakness, and entire body felt cool and clammy on an unspecified date in Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Neurological examination normal, Paraesthesia
Clinical narrative: Right hand felt cold at first but that sensation has subsided; Within less than 10 minutes I had a warm tingling feeling; heaviness in my legs which still continues over an hour later; Dry mouth; This is a spontaneous report from a contactable consumer reporting for herself. This 44-year-old female patient received on 17dec2020 10:00 first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot EK5730) at single dose in the right arm for immunization. Medical history included reflux. No allergies to medications, food, or other products. Concomitant medications included omeprazole (PRILOSEC). On 17Dec2020, within less than 10 minutes, the patient had a warm tingling feeling, heaviness in her legs which still continued over an hour later. Right hand felt cold at first, but that sensation has subsided. Also had a dry mouth about 15-20 minutes after the vaccine. All symptoms subsided after 2 1/2 hours. Patient went to emergency room. Final outcome was recovered on 17Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Feeling hot, Limb discomfort, Paraesthesia, Peripheral coldness
Clinical narrative: Right hand felt cold at first but that sensation has subsided; Within less than 10 minutes I had a warm tingling feeling; heaviness in my legs which still continues over an hour later; Dry mouth; This is a spontaneous report from a contactable consumer reporting for herself. This 44-year-old female patient received on 17dec2020 10:00 first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot EK5730) at single dose in the right arm for immunization. Medical history included reflux. No allergies to medications, food, or other products. Concomitant medications included omeprazole (PRILOSEC). On 17Dec2020, within less than 10 minutes, the patient had a warm tingling feeling, heaviness in her legs which still continued over an hour later. Right hand felt cold at first, but that sensation has subsided. Also had a dry mouth about 15-20 minutes after the vaccine. All symptoms subsided after 2 1/2 hours. Patient went to emergency room. Final outcome was recovered on 17Dec2020.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: 12/21@11:50-Caller stated that he had vaccine at 9am and  had a seizure about 4am the next morning. Patient also had slight head. Caller  stated that he is feeling better no medications were given .Caller had  Cat scan  and EEG.  Caller has follow up 12/22.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Headache, Laboratory test, Seizure
Clinical narrative: 12/21@11:50-Caller stated that he had vaccine at 9am and  had a seizure about 4am the next morning. Patient also had slight head. Caller  stated that he is feeling better no medications were given .Caller had  Cat scan  and EEG.  Caller has follow up 12/22.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Patient/Employee became dizzy 15 min after covid vaccine
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Patient/Employee became dizzy 15 min after covid vaccine
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Approximately 3 minutes after receiving the vaccine, I felt a flush of heat across my chest and I couldn?t swallow. My throat was closing. I notified the employees immediately and they called a code blue per hospital policy. I received epi IM and Benadryl IM and was transferred to the ED where I received solumedrol IV and Pepcid IV. I was monitored for 6 hours and was released with methyprednisolone.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hot flush, Pharyngeal swelling
Clinical narrative: Approximately 3 minutes after receiving the vaccine, I felt a flush of heat across my chest and I couldn?t swallow. My throat was closing. I notified the employees immediately and they called a code blue per hospital policy. I received epi IM and Benadryl IM and was transferred to the ED where I received solumedrol IV and Pepcid IV. I was monitored for 6 hours and was released with methyprednisolone.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: 15 Mins after I started noticing  tightness in chest, tongue swelling , heart rate 130 , 25 mg of Benadryl,, irregular heart
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Heart rate irregular, Swollen tongue
Clinical narrative: 15 Mins after I started noticing  tightness in chest, tongue swelling , heart rate 130 , 25 mg of Benadryl,, irregular heart
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Skin warm, Tachycardia
Clinical narrative: Flush, red, Tachycardia Tx : Benadryl
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Flushing, Tachycardia
Clinical narrative: Flush, red, Tachycardia Tx : Benadryl
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Pharyngeal swelling, Swollen tongue
Clinical narrative: approximately 30 minutes after the vaccine the patient began to experience itching and swelling of the throat and tongue.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swollen tongue, Throat irritation, Tongue pruritus
Clinical narrative: approximately 30 minutes after the vaccine the patient began to experience itching and swelling of the throat and tongue.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: 12/18/2020 ABOUT 5 MINUTES AFTER VACCINATION, STARTED TO FEEL DIZZINESS. 'IT WAS VERY WEIRD. LIKE I WAS MOVING. I MADE IT TO THE OTHER CHAIR'. I FELT MY LEGS GO NUMB, TINGLING IN ARMS AND LEGS. STAFF CALLED NURSE OVER. TOLD ME TO LIE DOWN ON THE FLOOR, STARTED TO CRY, 'DONT LIKE HOW MY FEET FEEL NUMB'. TOOK ME TO THE ER. TOLD MIGHT BE A 'NASAL VASOVAGAL REACTION'. DIDN'T LOSE CONSCIOUSNESS.  BUT THE TINGLING IS STILL GOING ON .
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crying, Dizziness, Electrocardiogram normal, Feeling abnormal, Hypoaesthesia
Clinical narrative: 12/18/2020 ABOUT 5 MINUTES AFTER VACCINATION, STARTED TO FEEL DIZZINESS. 'IT WAS VERY WEIRD. LIKE I WAS MOVING. I MADE IT TO THE OTHER CHAIR'. I FELT MY LEGS GO NUMB, TINGLING IN ARMS AND LEGS. STAFF CALLED NURSE OVER. TOLD ME TO LIE DOWN ON THE FLOOR, STARTED TO CRY, 'DONT LIKE HOW MY FEET FEEL NUMB'. TOOK ME TO THE ER. TOLD MIGHT BE A 'NASAL VASOVAGAL REACTION'. DIDN'T LOSE CONSCIOUSNESS.  BUT THE TINGLING IS STILL GOING ON .
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: 12/18/2020 ABOUT 5 MINUTES AFTER VACCINATION, STARTED TO FEEL DIZZINESS. 'IT WAS VERY WEIRD. LIKE I WAS MOVING. I MADE IT TO THE OTHER CHAIR'. I FELT MY LEGS GO NUMB, TINGLING IN ARMS AND LEGS. STAFF CALLED NURSE OVER. TOLD ME TO LIE DOWN ON THE FLOOR, STARTED TO CRY, 'DONT LIKE HOW MY FEET FEEL NUMB'. TOOK ME TO THE ER. TOLD MIGHT BE A 'NASAL VASOVAGAL REACTION'. DIDN'T LOSE CONSCIOUSNESS.  BUT THE TINGLING IS STILL GOING ON .
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Pruritus, Skin warm, Swelling face, Tachycardia
Clinical narrative: I had a rash that covered my neck, face and chest.  A slight fever of 99.5 , soreness in the shoulder and joint area, mild headache the day I got the  vaccine.  Next day, rash still on face, joint pain and mild headache.  Next day, joint pain.  Today, a mild headache. Did a telephone call from Dr. and nurse from Health Dept.  I was told to take Benadryl and go to ER if symptoms got worse.  I took Benadryl one and one-half days.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: I had a rash that covered my neck, face and chest.  A slight fever of 99.5 , soreness in the shoulder and joint area, mild headache the day I got the  vaccine.  Next day, rash still on face, joint pain and mild headache.  Next day, joint pain.  Today, a mild headache. Did a telephone call from Dr. and nurse from Health Dept.  I was told to take Benadryl and go to ER if symptoms got worse.  I took Benadryl one and one-half days.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Pyrexia, Rash
Clinical narrative: I had a rash that covered my neck, face and chest.  A slight fever of 99.5 , soreness in the shoulder and joint area, mild headache the day I got the  vaccine.  Next day, rash still on face, joint pain and mild headache.  Next day, joint pain.  Today, a mild headache. Did a telephone call from Dr. and nurse from Health Dept.  I was told to take Benadryl and go to ER if symptoms got worse.  I took Benadryl one and one-half days.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Disturbance in attention, Malaise
Clinical narrative: I was ok for first 15-20 mins post vaccine and was sitting in chair and calling family and friends When I stood up I felt 'funny"- kind of hard to describe I walked around and mostly felt ok but not hundred % but didn't feel dizzy but didn't feel 100% myself either I checked my radial pulse and it felt normal and there was no BP machine there to have a check done I left hoping to feel 100% soon  I walked to my car in the parking lot and started driving home Around 200 yards from the hospital I felt weird warm rush like feeling through my whole body Knowing that anaphylaxis can occur at this stage I panicked and  turned car around and went directly to ER to be checked out My BP was not low and I was observed for short duration and discharged home then- vitals were taken almost half an hour post vaccine Further records can be sought from ER as they should have reported this as well I also had arm pain/malaise and low grade temp of 100.5 at home for 24 hrs that resolved subsequently The initial  symptoms within first half an hour made me file this report
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Electrocardiogram, Feeling abnormal, Feeling hot, Malaise
Clinical narrative: I was ok for first 15-20 mins post vaccine and was sitting in chair and calling family and friends When I stood up I felt 'funny"- kind of hard to describe I walked around and mostly felt ok but not hundred % but didn't feel dizzy but didn't feel 100% myself either I checked my radial pulse and it felt normal and there was no BP machine there to have a check done I left hoping to feel 100% soon  I walked to my car in the parking lot and started driving home Around 200 yards from the hospital I felt weird warm rush like feeling through my whole body Knowing that anaphylaxis can occur at this stage I panicked and  turned car around and went directly to ER to be checked out My BP was not low and I was observed for short duration and discharged home then- vitals were taken almost half an hour post vaccine Further records can be sought from ER as they should have reported this as well I also had arm pain/malaise and low grade temp of 100.5 at home for 24 hrs that resolved subsequently The initial  symptoms within first half an hour made me file this report
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Panic reaction, Pyrexia
Clinical narrative: I was ok for first 15-20 mins post vaccine and was sitting in chair and calling family and friends When I stood up I felt 'funny"- kind of hard to describe I walked around and mostly felt ok but not hundred % but didn't feel dizzy but didn't feel 100% myself either I checked my radial pulse and it felt normal and there was no BP machine there to have a check done I left hoping to feel 100% soon  I walked to my car in the parking lot and started driving home Around 200 yards from the hospital I felt weird warm rush like feeling through my whole body Knowing that anaphylaxis can occur at this stage I panicked and  turned car around and went directly to ER to be checked out My BP was not low and I was observed for short duration and discharged home then- vitals were taken almost half an hour post vaccine Further records can be sought from ER as they should have reported this as well I also had arm pain/malaise and low grade temp of 100.5 at home for 24 hrs that resolved subsequently The initial  symptoms within first half an hour made me file this report
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Injection site oedema, Tachycardia, Throat tightness
Clinical narrative: Pt expressed feeling tachycardic, jittery, shaky, site edema, shortness of breath and dizziness.  Pt received epipen 0.3 mg IM injection x1 dose and benadryl PO, responded favorably and transported to ED for follow up care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Feeling jittery, Injection site oedema, Tachycardia
Clinical narrative: Pt expressed feeling tachycardic, jittery, shaky, site edema, shortness of breath and dizziness.  Pt received epipen 0.3 mg IM injection x1 dose and benadryl PO, responded favorably and transported to ED for follow up care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Pt expressed feeling tachycardic, jittery, shaky, site edema, shortness of breath and dizziness.  Pt received epipen 0.3 mg IM injection x1 dose and benadryl PO, responded favorably and transported to ED for follow up care.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Flushing, Injection site swelling, Myalgia
Clinical narrative: Employee reported purple discoloration to Right Arm and Right fingers. She stated her cap refill was sluggish, she had chills and a redness across her chest and stomach. Employee was evaluated and treated in emergency department.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Peripheral coldness, Rash erythematous, SARS-CoV-2 test negative, Skin discolouration
Clinical narrative: Employee reported purple discoloration to Right Arm and Right fingers. She stated her cap refill was sluggish, she had chills and a redness across her chest and stomach. Employee was evaluated and treated in emergency department.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Capillary nail refill test abnormal, Chills, Erythema, Skin discolouration
Clinical narrative: Employee reported purple discoloration to Right Arm and Right fingers. She stated her cap refill was sluggish, she had chills and a redness across her chest and stomach. Employee was evaluated and treated in emergency department.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Device malfunction, Product administration error, Underdose
Clinical narrative: Employee was being administered the PFizer vaccine and the needle retraction mechanism was activated only having provided a partial dose.  After consulting with Pharmacy, local Pharmacy and PFizer, a second dose was administered. Device failure identified and the needle/syringe accidently discarded. Employee received a second dose of the PFizer vaccine and was monitored for the required timeframe - exhibiting no adverse signs as a result of an additional dose.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event, Product delivery mechanism issue
Clinical narrative: Employee was being administered the PFizer vaccine and the needle retraction mechanism was activated only having provided a partial dose.  After consulting with Pharmacy, local Pharmacy and PFizer, a second dose was administered. Device failure identified and the needle/syringe accidently discarded. Employee received a second dose of the PFizer vaccine and was monitored for the required timeframe - exhibiting no adverse signs as a result of an additional dose.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Palpitations, Pharyngeal paraesthesia
Clinical narrative: December 18-after administration-flushing, rapid heartbeat, mouth tingling, throat felt like closing , received epinephrine, sq Benadryl and IV decadron December 18 at night- rapid heart rate, throat felt tighter , took Benadryl heart rate went down December 20- lower lip sores , chills, diarrhea, lower back pain
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Cheilitis, Chills, Diarrhoea, Flushing
Clinical narrative: December 18-after administration-flushing, rapid heartbeat, mouth tingling, throat felt like closing , received epinephrine, sq Benadryl and IV decadron December 18 at night- rapid heart rate, throat felt tighter , took Benadryl heart rate went down December 20- lower lip sores , chills, diarrhea, lower back pain
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Paraesthesia oral, Throat tightness
Clinical narrative: December 18-after administration-flushing, rapid heartbeat, mouth tingling, throat felt like closing , received epinephrine, sq Benadryl and IV decadron December 18 at night- rapid heart rate, throat felt tighter , took Benadryl heart rate went down December 20- lower lip sores , chills, diarrhea, lower back pain
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Pain, Paraesthesia
Clinical narrative: Approximately 30 minutes after vaccination developed intense pins and needles sensation to the left side of my face. I then developed a heavy, aching, tingling sensation to the left side of my face. I returned to the facility and was evaluated post vaccination. Symptoms persisted still 2 days later so I was evaluated by my PCP today and diagnosed with Bells Palsy. I was prescribed high dose steroids today.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Facial pain, Facial paralysis, Paraesthesia
Clinical narrative: Approximately 30 minutes after vaccination developed intense pins and needles sensation to the left side of my face. I then developed a heavy, aching, tingling sensation to the left side of my face. I returned to the facility and was evaluated post vaccination. Symptoms persisted still 2 days later so I was evaluated by my PCP today and diagnosed with Bells Palsy. I was prescribed high dose steroids today.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Erythema, Flushing
Clinical narrative: c/o feeling lightheadedness. Sat pt in chair. Had lunch @ noon and a snack around 2 pm. Gave OJ and wafer snack to pt. VS taken. Pt then proceeded to c/o chest heaviness and hands feeling cold. Noticed a raised wheal warm to touch on right side of face, VS taken. Hospital emergency activated, Epi pen given IM in right thigh. Also noticed another smaller wheal developing on pt's face along with redness in her throat area and on the top of pt's right ear. Emergency staff arrived and brought pt to the Emergency room for observation.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Palpitations, Paraesthesia
Clinical narrative: c/o feeling lightheadedness. Sat pt in chair. Had lunch @ noon and a snack around 2 pm. Gave OJ and wafer snack to pt. VS taken. Pt then proceeded to c/o chest heaviness and hands feeling cold. Noticed a raised wheal warm to touch on right side of face, VS taken. Hospital emergency activated, Epi pen given IM in right thigh. Also noticed another smaller wheal developing on pt's face along with redness in her throat area and on the top of pt's right ear. Emergency staff arrived and brought pt to the Emergency room for observation.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Erythema, Peripheral coldness, Skin warm
Clinical narrative: c/o feeling lightheadedness. Sat pt in chair. Had lunch @ noon and a snack around 2 pm. Gave OJ and wafer snack to pt. VS taken. Pt then proceeded to c/o chest heaviness and hands feeling cold. Noticed a raised wheal warm to touch on right side of face, VS taken. Hospital emergency activated, Epi pen given IM in right thigh. Also noticed another smaller wheal developing on pt's face along with redness in her throat area and on the top of pt's right ear. Emergency staff arrived and brought pt to the Emergency room for observation.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: c/o feeling lightheadedness. Sat pt in chair. Had lunch @ noon and a snack around 2 pm. Gave OJ and wafer snack to pt. VS taken. Pt then proceeded to c/o chest heaviness and hands feeling cold. Noticed a raised wheal warm to touch on right side of face, VS taken. Hospital emergency activated, Epi pen given IM in right thigh. Also noticed another smaller wheal developing on pt's face along with redness in her throat area and on the top of pt's right ear. Emergency staff arrived and brought pt to the Emergency room for observation.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Hypertension, Hypoaesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: NUMBNESS IN THE THROAT AND BACK OF TONGUE.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: NUMBNESS IN THE THROAT AND BACK OF TONGUE.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: NUMBNESS IN THE THROAT AND BACK OF TONGUE.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Laboratory test, Muscle tightness, Throat tightness
Clinical narrative: Bottom lip numb and lower jaw and throat tight
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: Dizzy, tired, weak, nausea, joint pain. I am resting and still feeling the effects. But slowly getting better.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: 10/28/2020:  She states initially had pain at injection site. She also has had some pain radiating to left scapular area as well as down to her thumb.   She went back to her office and became nauseated /queasy and felt lightheaded x 1 hour.  3 hours post injection, she has decreased shoulder ROM Limited with flexion and abduction, external rotation, and horizontal adduction Hurts with movement. Currently, using anti-inflammatories, icing.  11/02 -Reports that shoulder is improving; however, there is pain with sleeping. Reports that if she doesn't do ROM exercises hourly, increased pain Pain with flexion, abduction, and horizontal adduction, but ROM is improved. Strength is ok.   12/14 - Shoulder continues to be bothersome - Appointment made with Ortho Plan:  Continue home exercise program          RX:  Celebrex          Recheck 2/15/2021
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Nausea, Pain, Pain in extremity
Clinical narrative: 10/28/2020:  She states initially had pain at injection site. She also has had some pain radiating to left scapular area as well as down to her thumb.   She went back to her office and became nauseated /queasy and felt lightheaded x 1 hour.  3 hours post injection, she has decreased shoulder ROM Limited with flexion and abduction, external rotation, and horizontal adduction Hurts with movement. Currently, using anti-inflammatories, icing.  11/02 -Reports that shoulder is improving; however, there is pain with sleeping. Reports that if she doesn't do ROM exercises hourly, increased pain Pain with flexion, abduction, and horizontal adduction, but ROM is improved. Strength is ok.   12/14 - Shoulder continues to be bothersome - Appointment made with Ortho Plan:  Continue home exercise program          RX:  Celebrex          Recheck 2/15/2021
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Tachycardia
Clinical narrative: Tachycardia, nausea, tingling
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Rash
Clinical narrative: Rash, Headache, sore throat.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough
Clinical narrative: Previously diagnosed with COVID 19 11/7/2020  and had a mild residual cough that was improving and almost completely resolved. Post vaccine this cough recurred. The presentation and frequency increased and was similar to that of when I was actively infected. This cough has worsened over the days following the vaccine.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity, Tendonitis
Clinical narrative: arm and shoulder pain for over 2 1/2 months after vaccination. Because of Covid, talked to my dr via phone, email, video. Use ice, massage and stretch. She diagnosed as tendinitis. She refer me to a physical therapist, had video conference. He gave me some exercises to do and will meet in 2 weeks
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Woke with very swollen and numb upper lip.  Took Benadryl and Acetaminophen.  Symptoms have greatly reduced over the course of the day.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  Pain at injection site   Fatigue Felt ?feverish?
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence
Clinical narrative: 12/19/2020  in the evening Started with  frequent flatus . Then stomach cramps early in the morning of Sunday 12/20/2020  at 4am following with diarrhea.  Took Imodium 2 tablet after first loose stool. Then  another 1 tablet  with the second loose stool.  Diarrhea continues intermittently. Took another anti-diarrheal medication: Pepto-Bismol Liquid form.  Since then diarrhea slowed down.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pins and needles sensation in L foot began 10 minutes after injection and is still occurring intermittently at this time.  Lowe left leg numbness occurring 45 minutes after injection and still occurring infrequently.  Pins and needles sensation to left hand and numbness occurring to posterior left forearm 45 minutes after injection and still occurring infrequently.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebellar ataxia
Clinical narrative: CEREBELLAR ATAXIA
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Chest discomfort, Tachycardia, Tremor
Clinical narrative: shakiness, tachycardia, breathing feels tight - went to emergency dept
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: syncope following vaccine
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pfizer-BioNTech COVID 19
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia, Laboratory test normal, Paraesthesia, Rash
Clinical narrative: rash across chest. numbness tingling across arm (injected arm).  Bendadryl & solumedrol given, returned to ed the next day with tightness in throat & trouble swallowing - Benadryl & solumedrol given - improvement
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: rash across chest. numbness tingling across arm (injected arm).  Bendadryl & solumedrol given, returned to ed the next day with tightness in throat & trouble swallowing - Benadryl & solumedrol given - improvement
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count, Dizziness, Erythema, Full blood count, Hypersensitivity
Clinical narrative: rash across chest. numbness tingling across arm (injected arm).  Bendadryl & solumedrol given, returned to ed the next day with tightness in throat & trouble swallowing - Benadryl & solumedrol given - improvement
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site reaction, Metabolic function test, Paraesthesia
Clinical narrative: rash across chest. numbness tingling across arm (injected arm).  Bendadryl & solumedrol given, returned to ed the next day with tightness in throat & trouble swallowing - Benadryl & solumedrol given - improvement
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Pharyngeal swelling, Rash, Rash erythematous, Swelling face
Clinical narrative: rash across chest. numbness tingling across arm (injected arm).  Bendadryl & solumedrol given, returned to ed the next day with tightness in throat & trouble swallowing - Benadryl & solumedrol given - improvement
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Night sweats
Clinical narrative: Night sweats and fatigue  on 12/19/20-Current
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Influenza like illness, Sleep disorder, Weight bearing difficulty
Clinical narrative: Severe right ankle monoarticular arthritis that woke from sleep. (did experience flu-like symptoms ~36 hrs after inoculation but these were short-lived). Unable to weight-bear despite high dose NSAIDS. While have hx of mild enthesitis, have never had these symptoms before.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site rash, Rash pruritic
Clinical narrative: When I got home to take a shower, I noticed a small rash under the arm of where I got the injection. It was a little itchy. I took benedryl. The only other symptoms I had was joint achiness and tiredness.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: left arm itchiness, observed patient itchiness did not worsen patient went home
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: I started having chills at 3pm At 10pm that night, I developed a fever, continued chills, body aches, fatigue, and nausea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Experienced angioedema approximately 24 hours post inoculation. Administered 50mg oral Benadryl with no response. No respiratory distress.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Morning after injection patient reported bilateral rash with some itch from elbow down
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: severe swelling and redness to his left upper arm area where he received the influenza vaccine.  moderate swelling to the left upper arm with a large reddened area with a vague border.  It does not appear to be urticarial but consistent with a severe local reaction.  instructed to get vitamin C and take 10,000 mg daily in divided doses until the reaction has resolved. soak completely in an Epson salts bath with his arm submerged for about 15 minutes daily which may help.  Ibuprofen can be used for pain or discomfort.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Feeling hot, Laboratory test normal, Nausea
Clinical narrative: felt hot, lightheaded, nausea
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache for 1 day Severe nausea lasting more than 3 days
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Laboratory test normal, Pain in extremity
Clinical narrative: First, my arm starting hurting  and is still a little sore.  That night, every bone in my body started aching. From the bones in my hands (the knuckles to the bottoms of my feet.   The next morning I got up and took a bath with alcohol, and epson salt.  Afterwhich, I felt much better.  Only my arm still hurts.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient not experiencing any adverse reactions; patient received an expired dose; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions/ allergies and concomitant medications was provided.  On 23-NOV-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 25 U/0.5 ml, lot # S032056, expiration date 09-NOV-2020, 1 injection (route of administration and anatomical location was not provided) for prophylaxis. No additional adverse reactions were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product dispensing error
Clinical narrative: No adverse event; A alternate dosing interval for GARDASIL 9; Error ocurred during dispensing; This spontaneous report as received from a registered nurse and refers to a 18-year-old male patient. The patient's medical history, concomitant medications, previous drug reactions and allergies were not reported. The patient had no concurrent illnesses.  On 05-OCT-2020 the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis.  On 30-NOV-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the left deltoid, lot# 1687290, expiration date 06-SEP-2022 (dose was not reported) for prophylaxis.  The registered nurse reported that the patient inadvertently received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) early due to dispensing error. The patient did experience any adverse events. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal
Clinical narrative: Patient stated that 45 minutes after receiving the vaccine he became dizzy and foggy, requiring the individual to sit down for a period of time as they felt unsteady on their feet.  No treatment was given, patient decided to have spouse pick them up and go home.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE reported; Temperature excursion on MMR II and Varivax. The vaccines were administered; This spontaneous report has been received from a non health care professional concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the following vaccines:  -  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II)  formulation not reported but defaulted to subcutaneous injection, 0.5 ml,  Lot # S006051, expiration date 27-FEB-2021 ( a second Lot # was reported: S015427, expiration date 20-MAY-2021) for prophylaxis (dosage regimen and anatomical location was not reported).    - varicella virus vaccine live (oka/merck)(VARIVAX) formulation not reported but defaulted to subcutaneous injection, 0.5 ml, Lot # S002740, expiration date 28-JAN-2021( a second Lot # was reported: S031494, expiration date 07-OCT-2021) for prophylaxis (dosage regimen and anatomical location was not reported).    On 28-SEP-2020, it was identified that the aforementioned vaccines had been involved in a temperature excursion.   The storage temperature for both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) and  varicella virus vaccine live (oka/merck)(VARIVAX)  was reported to had been at 5.7 °Fahrenheit (F) for a period of 14 hours.    No other adverse event was reported, there was digital data logger involved and no previous temperature excursion was reported.; Sender's Comments:  US-009507513-2012USA001631:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Headache, sore throath
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pharyngeal swelling
Clinical narrative: Approximately 14 minutes post vaccination  -- developed numbness and tingling in L arm and "swelling" in throat.  Denies antecedent illness, allergies, medication use. Member was observed for 1 hr and 45 minutes.  No dyspnea, wheezing or chest pain.  BP 142/100, P 98, SpO2 98% on RA.  Released to home  after symptoms largely resolved.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Ultrasound scan
Clinical narrative: Left axillary enlarged lymph node. The lymph node has increased in tenderness and size
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Urticaria
Clinical narrative: Hives and Throat Swelling - treated with epinephrine and steroid
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Headache, Myalgia, Pyrexia
Clinical narrative: STRONG PERSISTENT HEADACHE GENERALIZED MYALGIA BACK PAIN UNQUANTIFIED FEVER WEAKNESS
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: no AE; an expired dose of PROQUAD that was administered; This spontaneous report has been received from a consumer referring to herself or himself with unknown gender and age. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not provided.  On 02-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: recombinant human albumin (rHA) strength, dose, frequency and route not provided, lot number S017251 has been verified to be a valid lot number, expiration date was 01-DEC-2020) (expired product administered) for prophylaxis. No adverse event reported (no adverse event). The outcome of both events were unknown.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: The patient is not having adverse signs and symptoms at this time; have a patient in my office, and I gave him a PNEUMOVAX 23 vaccine that expired on 03-DEC-2020; This spontaneous report was received from a physician referring to a 66-year-old male patient. The patient's concurrent conditions included thyroid disorder, hypertension, dyslipidaemia, and lipids increased. His medical history and drug reactions/allergies were not reported. Concomitant medications included levothyroxine sodium, atorvastatin, and amlodipine.  On 04-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter, intramuscular injection in the left arm (lot number not provided), with an expiration date reported as 03-DEC-2020 (expired product administered) for routine immunization for patients 65 and older. The reporter wanted to know if it was okay to give the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) past the expiration date. No treatment was given, the patient did not seek medical attention, and the present status was reported as recovered. At the time of the report, the patient was not having adverse signs and symptoms. No product quality complaint reported.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: runny diarrhea; This spontaneous report was received from the patient's mother referring to a 4 months old female patient. The patient's concomitant medication, pertinent medical history, drug reactions/ allergies was reported as none.     On 02-DEC-2020, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, strength, lot# and expiration date were not reported) orally for routine vaccination.         On 04-DEC-2020 (reported as today), the patient had runny diarrhea. Lab diagnostics/studies performed was reported as none. Information about treatment and sought medical attention was not provided. The outcome of the event was reported as not recovered.        The relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.