chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Bone pain, Hemiparesis, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Left leg pain, increasing in intensity over 2 1/2 weeks requiring treatment.  Sharp pain down leg, with an achiness in bones of entire leg, numbness in toes at times, with increasing weakness.  Received Doppler scan, X-rays,  and MRI with no know problems seen.  Required treatment of prednisone, anti-inflammatory meds, Percocet, gabapentin, as well as epidural.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Ultrasound Doppler, X-ray
Clinical narrative: Left leg pain, increasing in intensity over 2 1/2 weeks requiring treatment.  Sharp pain down leg, with an achiness in bones of entire leg, numbness in toes at times, with increasing weakness.  Received Doppler scan, X-rays,  and MRI with no know problems seen.  Required treatment of prednisone, anti-inflammatory meds, Percocet, gabapentin, as well as epidural.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Numbness in throat and arm, bp 137/87,    100% oxygen     heart rate 72.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Injection site pain, Myalgia, Nausea
Clinical narrative: Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vision blurred
Clinical narrative: Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Lethargy, Pain in extremity
Clinical narrative: Pt reports 24 hours after receiving vaccine having chills, fever of 101.9, arm pain. lethargy, and HA Pt reports she had to miss a day of work and never misses work.   At time of interview on 1/14/21 patient was feeling back to normal and said she felt fine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pt reports 24 hours after receiving vaccine having chills, fever of 101.9, arm pain. lethargy, and HA Pt reports she had to miss a day of work and never misses work.   At time of interview on 1/14/21 patient was feeling back to normal and said she felt fine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gastrooesophageal reflux disease, Nausea, Urticaria
Clinical narrative: Vaccine received on 1/7/21. Joint pain, nausea, gastric reflux started on 1/9/21. Generalized hives started on 1/11/21. Symptoms improved with Zofran, Pepcid and Benadryl.  Symptoms resolved on 1/15/21. Patient had a history of COVID 19 virus infection in October 2020.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Nausea, Vital signs measurement
Clinical narrative: During 15 minute observation period after administration of Moderna vaccine, patient reported feeling dizzy and nauseous. Patient was transferred into wheelchair and brought into an examination room with provider NP. Provider and staff collected vitals, blood sugars, and HPI. Patient reported he "felt like he was going to pass out" but did not actually syncopize. Patient was with staff for well over one hour for observation, and symptoms resolved within 15 minutes of the initial onset without intervention. It was deemed likely vasovagal response by the provider.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and fingertips.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Night sweats, Pyrexia
Clinical narrative: Developed a fever of 101.8, night sweats, nausea, fatigue, for two days
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Fatigue, Full blood count, Hypoaesthesia
Clinical narrative: Symptoms of 2nd Covid vaccine lot EL 1284: numbness in feet, legs throbbing, muscle weakness in legs, overall tiredness  I received my second Pfizer vaccine on 1/12/21 at 12:15 pm.  After several hours, I felt weak and tired.  By 7:00 pm, I had a migraine that wouldn?t go away and I had muscle ache in my feet and legs.  On 1/13/21 I felt some numbness in my feet and my legs were throbbing.  By 10:00 pm, both of my feet were completely numb and my legs were throbbing/radiating heat.  It felt as if circulation was cut off from my feet entirely.  On 1/14/21 I went into work where I?m constantly on my feet.  I felt intense muscle weakness in my legs and thighs to point where I could barely stand up.  I immediately went to an urgent care where they started me on an Sodium Chloride 0.9% intravenous IV solution drip.  They ran blood tests and urine tests to rule out any other causes to my symptoms.  All results came back negative.  I was told to rest, hydrate, and recover for the next several days.  If my symptoms did not subside within the next couple days, I was instructed to go to the ER for further examination.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test normal, Migraine, Muscular weakness, Myalgia, Pain
Clinical narrative: Symptoms of 2nd Covid vaccine lot EL 1284: numbness in feet, legs throbbing, muscle weakness in legs, overall tiredness  I received my second Pfizer vaccine on 1/12/21 at 12:15 pm.  After several hours, I felt weak and tired.  By 7:00 pm, I had a migraine that wouldn?t go away and I had muscle ache in my feet and legs.  On 1/13/21 I felt some numbness in my feet and my legs were throbbing.  By 10:00 pm, both of my feet were completely numb and my legs were throbbing/radiating heat.  It felt as if circulation was cut off from my feet entirely.  On 1/14/21 I went into work where I?m constantly on my feet.  I felt intense muscle weakness in my legs and thighs to point where I could barely stand up.  I immediately went to an urgent care where they started me on an Sodium Chloride 0.9% intravenous IV solution drip.  They ran blood tests and urine tests to rule out any other causes to my symptoms.  All results came back negative.  I was told to rest, hydrate, and recover for the next several days.  If my symptoms did not subside within the next couple days, I was instructed to go to the ER for further examination.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Urine analysis
Clinical narrative: Symptoms of 2nd Covid vaccine lot EL 1284: numbness in feet, legs throbbing, muscle weakness in legs, overall tiredness  I received my second Pfizer vaccine on 1/12/21 at 12:15 pm.  After several hours, I felt weak and tired.  By 7:00 pm, I had a migraine that wouldn?t go away and I had muscle ache in my feet and legs.  On 1/13/21 I felt some numbness in my feet and my legs were throbbing.  By 10:00 pm, both of my feet were completely numb and my legs were throbbing/radiating heat.  It felt as if circulation was cut off from my feet entirely.  On 1/14/21 I went into work where I?m constantly on my feet.  I felt intense muscle weakness in my legs and thighs to point where I could barely stand up.  I immediately went to an urgent care where they started me on an Sodium Chloride 0.9% intravenous IV solution drip.  They ran blood tests and urine tests to rule out any other causes to my symptoms.  All results came back negative.  I was told to rest, hydrate, and recover for the next several days.  If my symptoms did not subside within the next couple days, I was instructed to go to the ER for further examination.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Palpitations, Paraesthesia, Throat tightness, Vital signs measurement
Clinical narrative: This patient received her first dose of Moderna vaccine and was then sent to the observation area. Within 10 minutes of vaccine receipt, she began complaining of a fast heart beat and some tightness in the throat. Emergency services was called immediately and she was placed supine in a stretcher. Her initial vitals were: heart rate of 130 beats/minute and oxygen saturation of 95%. Repeated vitals were as follows: 11:25- BP 162/94,HR 123, SO2- 98% 11:30- BP 161/81 HR 101, SO2- 96% 11:35- BP 160/106 HR 95, SO2- 96% 11:35 - BP 157/96 HR 96, SO2- 95%  complaining of tingling in fingers. 11:40- BP 162/79 HR 91, SO2- 96%  11:45- BP 152/84HR 92, SO2- 95% denies chest pain, shortness of breath, or throat tightness at this time.   Patient felt better within 20 minutes and was taken to the emergency department for evaluation. In the emergency department, she was encouraged to obtain the remainder of the work up but declined and elected to go home. She denied rashes, respiratory distress, or itching at the time of discharge from the emergence department. She planned to follow up with her outpatient primary care provider.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Injection site erythema, Injection site pain, Injection site warmth, Lymph node pain
Clinical narrative: Erythema of injection site with warmth and tenderness. Area of erythema approximately 10 cm in circumference. Enlarged, tender lymph node on axilla of the same side. Breast tenderness on same side of vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Erythema of injection site with warmth and tenderness. Area of erythema approximately 10 cm in circumference. Enlarged, tender lymph node on axilla of the same side. Breast tenderness on same side of vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain, Urticaria
Clinical narrative: Vaccinated 1/11/2021 at 11:30 AM, at approx. 10 PM experienced moderate pain scale diffuse body aches. This lasted a few hours, improved with advil. After body aches subsided at around 2 AM  1/12/2021  experienced mild allergic reaction of hives and lip swelling. This allergic reaction subsided by morning 1/12 with benadryl.   I have never had any side effects or allergic reaction to a vaccine.   I did experience similar mild allergic reaction with antibiotic bactrim, a sulfa based medication.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Malaise, Nausea
Clinical narrative: after I received the shot I was sick for 3 days, chills, nausea, upset stomach
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia, Lethargy, Nausea
Clinical narrative: lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Pruritus, Rash
Clinical narrative: Severe rash over entire body, itching
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: 1015-felt dizzy; tingling starting in hands and feet.  EE ate a granola bar and drank some water and related she was feeling much better
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: After 7 days of no symptoms (other than a sore arm on day 2), I suddenly experienced extreme itchiness at the injection site and has a large, firm welt about 2 inches in diameter that appear inflamed and white. This lasted for 2 days. I reported it to my employee health department at Hospital and the triage nurse did not seemed concerned but recommended I go to urgent care if I felt that I needed to be seen (which I did not). I asked if anyone might follow up with me and she did not seem to think it was necessary.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperaesthesia, Nausea, Pain
Clinical narrative: 10 hours after vaccine, developed fever of 99.4 and chills.  Achy in joints.  500mg Tylenol taken at 2:15 amAnother 500 mg taken at 5:45am  Around 7am chills began to subside but fever remained and actually increased ton100.6. At 12noon pm another 1000mg of Tylenol taken. Body aches still present and skin very sensitive to the touch.  At 1pm temp has risen to 102.1 even after Tylenol 1 hour prior.  Some mild nausea now present
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 10 hours after vaccine, developed fever of 99.4 and chills.  Achy in joints.  500mg Tylenol taken at 2:15 amAnother 500 mg taken at 5:45am  Around 7am chills began to subside but fever remained and actually increased ton100.6. At 12noon pm another 1000mg of Tylenol taken. Body aches still present and skin very sensitive to the touch.  At 1pm temp has risen to 102.1 even after Tylenol 1 hour prior.  Some mild nausea now present
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: When changing clothes, I noticed injection shot area bright red & hot to the touch (approx. 3-1/2 in. x 3-1/2 in size). I rubbed the area, & it started to welt & itch. The site today (approx. 15 hrs. later) is still red & hot to the touch.  Yesterday would have been 10 days since the injection.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: 24 hours after vaccine injection site was red and warm to tough then after 2 days a bruise about the size of an egg above where the injection site appeared
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Fever, chills, nausea, bodyaches, headache, fatigue.  my arm at the injection site is extremely painful.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, nausea, bodyaches, headache, fatigue.  my arm at the injection site is extremely painful.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe Joint Pain
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 36 Hours later I noticed that I was scratching my  knuckles.. Very red and inflamed  and tiny bumps .. One knuckles on left hand and two knuckles on my right hand
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Tenderness
Clinical narrative: After injection there was a large knot at the injection site and was very sore for a couple of days. Two weeks after vaccine I had an appointment with my dermatologist. She noticed there was still a large red area around the injection site. It is no longer tender and does not itch however she felt I should report it. As of today the large red area is still there.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Malaise, Nausea, Vital signs measurement
Clinical narrative: Pt notified observers she was not feeling well. Was found diaphoretic, light headed, dizzy and nauseous. Pt was transferred to stretcher. Rapid Response was called 0748  BP 100/57 HR 63 O2 98%, 0752 BP 89/51 HR62 O2 98% 0754 BP 84/42 HR 93 O2 98% due to drop in BP was taken to the ER, remained oriented. Handoff to the ER staff.  Unable to reach due to no phone number on form.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of distal arm.  Vital signs within normal limits.  Patient improved.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspnoea, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Rigors, itching at vaccine site, extreme swelling at vaccine site, heart pounding, breathlessness, severe pain everywhere in my body
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations
Clinical narrative: Rigors, itching at vaccine site, extreme swelling at vaccine site, heart pounding, breathlessness, severe pain everywhere in my body
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Heart rate increased, Illness, Inflammation, Injection site erythema
Clinical narrative: Rigors, itching at vaccine site, extreme swelling at vaccine site, heart pounding, breathlessness, severe pain everywhere in my body
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Rigors, itching at vaccine site, extreme swelling at vaccine site, heart pounding, breathlessness, severe pain everywhere in my body
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Myalgia, Pyrexia
Clinical narrative: Fever chills, stomach pain,  muscle aches
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest pressure/tightness starting approximately 24h after the vaccine. No allergic reaction or sign of anaphylaxis. No shortness of breath or trouble breathing, just general chest tightness. Got a little better the next day, but still a bit of chest tightness. Almost feels like the type of chest pressure you get when you have a bad cold with postnasal drip.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Client reported rapid heart rate and tingling in face.  BP 123/80  pulse 83 @12:59.  She stated feeling better before leaving.  Encouraged client to follow up  with PCP if  experienced any other symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Tachycardia
Clinical narrative: Rapid heart rate into the 120-130's with increased blood pressure
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chest pain, Electrocardiogram, Hypoaesthesia, Limb discomfort
Clinical narrative: Chest pain, left arm numbness, tingling, and heaviness cold feeling to fingers O2 sats 88% from 99% then reounded back to 99 Ativan 1mg tab  Aspirin 324mg
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Chest pain, left arm numbness, tingling, and heaviness cold feeling to fingers O2 sats 88% from 99% then reounded back to 99 Ativan 1mg tab  Aspirin 324mg
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Rhinorrhoea
Clinical narrative: Difficulty swallowing, coughing and runny nose
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS and a Little head ache
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Impaired work ability, Lip swelling, Swelling face
Clinical narrative: At work 24 hours after vaccine administration - Lip swelling, jaw swelling  increased BP - patient has anxiety Benadryl and prednisone provided, staff member was sent home from work, PCP called patient advised to rest and monitor swelling - if swelling continued notify physician.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 10 days after the vaccine the injection sight and surrounding tissue is hard, red, hot, itchy, and swollen.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: -Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprofen). -Chills with shaking -Nausea/diarrhea -Body aches and joint pain -Fatigue
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: -Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprofen). -Chills with shaking -Nausea/diarrhea -Body aches and joint pain -Fatigue
Age: 75.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain, Diarrhoea, Gastrointestinal disorder, Pyrexia
Clinical narrative: 9/17/2020- Fever 9/18/2020- Intense watery diarrhea, abdominal pain, fever 9/19/2020- Called ER and reported continued symptoms above. Nurse in ER advises an antidiarrheal be taken. Patient follows instructions with no relief. 09/20/2020- Symptoms continue and patient goes to ER in the morning. Dr. evaluates and tells patient he does not believe the symptoms are vaccine related. Gives IV fluids for dehydration and prescribes oral medication for gastro symptoms.  09/22/2020- Patient feels fully recovered from illness.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Skin mass
Clinical narrative: Day number 8 woke up with a red spot approx the size of a baseball, hot to touch
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pruritus, Rash, Skin warm
Clinical narrative: Delayed adverse reaction day 9 (1/7/21) arm was itchy. By nighttime red bullseye type mark on arm. No response to OTC hydrocortisone. On Friday, Saturday, and Sunday I took over the counter day time allergy meds without much relief.  Spot on arm continued growing nearly to elbow and was hot to touch. Sunday night switched to Benadryl. Itchy throughout entire body- tingly lips and nose, but no swelling to tongue.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness - lasted only about 15-20  minute=s
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Paraesthesia, Pruritus, Sensory loss
Clinical narrative: Patient experienced localized itching, redness & heat at the injection site, pins and needle type pain & loss of sensation in the lower extremity within 20 min of administration.  Patient denied N&V, SOB, difficulty breathing, headache, dizziness, hives, facial/tongue swelling, light headiness, or clammy skin.  Vitals taken at 5 minute intervals include BP 121/62; 109/61; 113/62, HR 79,70, 65, 02 98, 98, 99.  Patient given 10mg cetirizine upon presentation of symptoms.  Patient returned to baseline ~ 20 minutes after administration of cetirizine.  Released with return precautions ~45 min post administration.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal and upper arm.  Vital signs within normal limits.  Improved
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: Nausea Stomach Pain Headache
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hot flush, Malaise
Clinical narrative: Chills, Malaise, Hot Flashes - All symptoms waxing and waning in severity, present from 0230 - 2230 on 01/14.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Migraine, Myalgia, Paraesthesia oral, Throat irritation
Clinical narrative: c/o "scratchy throat" said tongue "felt funny", had a migraine and very achy joints and muscles.  Took benadryl and ibuprofen, felt better the next day, today (1/15/2021) feels 100% and "arm not even sore".
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Impaired work ability, Pain in extremity, Skin warm, Swelling
Clinical narrative: Left arm severe pain, swelling, redness, and hot to touch
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, SARS-CoV-2 test negative
Clinical narrative: Moderna COVID-19 Vaccine EUA Itching, swelling, redness and warm to touch - noticed this morning (January 15, 2021) Size 2.5 inches up & down length and 2 inches wide  I experienced these similar injection site reactions 3 days after vaccine injected on January 5, 2021 but they subsided within 24 hours.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Moderna COVID-19 Vaccine EUA Itching, swelling, redness and warm to touch - noticed this morning (January 15, 2021) Size 2.5 inches up & down length and 2 inches wide  I experienced these similar injection site reactions 3 days after vaccine injected on January 5, 2021 but they subsided within 24 hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches, fever, headache, fatigue.  Still currently have symptoms
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Peripheral swelling, Rash pruritic
Clinical narrative: Arm started swelling  with some discomfort  at injection site and  itchy rash developed .
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Injection site swelling
Clinical narrative: Patient  stated, " I have soreness under the left arm and noticed a one inch bump under my left arm on my lymph node."
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hot flush, Hyperhidrosis, Nausea
Clinical narrative: Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Pain in extremity, Purpura
Clinical narrative: Unusual pattern of bruising at injection site - bruising with 3 reddish/purplish small round circles underneath the skin.  Circles are all approximately the same size, and all are on the same horizontal "line".  Bruising started appearing evening of the injection. Left arm was very sore, especially the evening of the injection. Bruising and circles still visible two days later, but pain is negligible.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV5
Symptoms: Wrong product administered
Clinical narrative: Hep A given to patient instead of Hep B. MA noticed the error immediately and notified MA Supervisor. Clinician was also notified. Dr stated that no adverse effects should be experienced by patient.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Patient describes chills, body aches, headache and fatigue.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Skin induration, Skin warm
Clinical narrative: Jan 7, around the size of a half dollar. Itchy, red, very warm to touch, slightly hard.  Jan 10, less itchy more of a burning feeling, not hard, not as red. Jan 12, no burning but itches slightly when touched, not hard, more pink.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Hypotension
Clinical narrative: Before receiving vaccine, patient was visibly anxious and fearful of the shot.  Within 5 minutes of receiving vaccine, patient complained of lightheadedness.  Vital signs showed slight hypotension which improved with hydration.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: few days later after the shot at 2am my wife woke up with chills headache and no fever. 1/14 no symptoms. 1/15 My wife woke up with chills and sever headaches.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Hypoaesthesia, Muscle tightness
Clinical narrative: On 1/12 at about 6:30 AM, I felt muscle tightness on the left side.  The whole right ring finger was numb and lock.  Within minutes, I felt tingling sensations along all my fingers and thumbs.  Then numbness at the tips.  Then, both my hands were very cold. At about 2- 3, I fell groggy, tired.  Then came the chill and fever, also light headaches.  The numbness was gone.  1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight.  I tried to uncurl them.  But they stayed locked.  It lasted about 1-2 minutes.  I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm.  Then at around 10 pm, I had bad warped vertigo.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness, Productive cough, Pyrexia, Somnolence
Clinical narrative: On 1/12 at about 6:30 AM, I felt muscle tightness on the left side.  The whole right ring finger was numb and lock.  Within minutes, I felt tingling sensations along all my fingers and thumbs.  Then numbness at the tips.  Then, both my hands were very cold. At about 2- 3, I fell groggy, tired.  Then came the chill and fever, also light headaches.  The numbness was gone.  1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight.  I tried to uncurl them.  But they stayed locked.  It lasted about 1-2 minutes.  I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm.  Then at around 10 pm, I had bad warped vertigo.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Trigger finger, Vertigo
Clinical narrative: On 1/12 at about 6:30 AM, I felt muscle tightness on the left side.  The whole right ring finger was numb and lock.  Within minutes, I felt tingling sensations along all my fingers and thumbs.  Then numbness at the tips.  Then, both my hands were very cold. At about 2- 3, I fell groggy, tired.  Then came the chill and fever, also light headaches.  The numbness was gone.  1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight.  I tried to uncurl them.  But they stayed locked.  It lasted about 1-2 minutes.  I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm.  Then at around 10 pm, I had bad warped vertigo.
Age: 15.0
Sex: M
Vaccine: IPV, MMR, MNQ, VARCEL
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Encephalopathy, Fatigue
Clinical narrative: Confusion (encephalopathy) and fatigue.  Onset about 10 hrs after shot.  Did not know how to dial a cellphone, did not realize I did not have glasses on, sent pt prescription to wrong pharmacy.  Was also extremely fatigued. Slept most of 1/14/21.  Confusion resolved 1/15/21, but still tired although better by 60% at 10 am on 1/15/21.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Blister rupture, Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Vaccine was adminstered subcutaneously instead of IM.  It blistered and broke open, small amount of liquid.  The administration was done close to shoulder joint.  Photos are available.   PLEASE ADVISE:  Should I get 2 IM vaccine administrations?
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Hypoacusis, Incorrect route of product administration, Underdose
Clinical narrative: Vaccine was adminstered subcutaneously instead of IM.  It blistered and broke open, small amount of liquid.  The administration was done close to shoulder joint.  Photos are available.   PLEASE ADVISE:  Should I get 2 IM vaccine administrations?
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea, Rheumatoid arthritis
Clinical narrative: 4pm 102.5 - 72-24 93% RA dizzy, nausea, headache, c/o SOB, Acetaminophen 650mg PO given, cooling measures started 6 pm Benadryl 50mg PO, 102.5-72-22 126/62 no c/o SOB, cooling measures, no acute distress noted 8pm 98.7-84-20 140/76 94% RA, no acute distress noted, fluids taken 1-15 1am 101-99-18 93% RA sleeping, Benadryl 50mg PO, Acetaminophen 650mg PO given 730am 97.8-76-18 118/72 94% RA reports feels good, ate 100% of breakfast, acting usual self
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: She denies any further AE/PQC; patient has received the supported vaccine prior to temperature excursion evaluation; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-DEC-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # T017688, expiration date 21-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of - 6.7 degrees Celsius for 22 hours.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported.; Sender's Comments:  US-009507513-2012USA013037:
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reported temperature excursion / Caller reported multiple administrations of both products / Temperature -13.3 C; This spontaneous report was received from a registered nurse and refers to a 13-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 03-DEC-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T017688, expiration date 21-MAY-2022, 0.5 milliliter for prophylaxis (anatomical location and route of administration were not reported).  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as -13.3 degrees of Celsius for 4 hours and 15 minutes. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA000235: US-009507513-2012USA013093: US-009507513-2012USA013532: US-009507513-2012USA013501: US-009507513-2012USA013524: US-009507513-2012USA013533: US-009507513-2012USA013539: US-009507513-2012USA013584: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013596: US-009507513-2012USA013598: US-009507513-2012USA013603: US-009507513-2012USA013601: US-009507513-2012USA013501: US-009507513-2012USA013095:
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Disseminated varicella zoster virus infection, Herpes zoster
Clinical narrative: SHINGLES; Information has been received from a lawyer and an elderly patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 19-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, in or about January 2016, the patient was treated by a provider for the following injures resulting from zoster vaccine live (ZOSTAVAX): shingles(onset date unknown). The outcome of the event shingles was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of VAQTA was administered; No further AE; This spontaneous report was received from a medical assistan and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  In January 2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # T008149 with expiration date on 06-JAN-2021 for prophylaxis (dose and route of administration was not reported). However, no adverse events were reported.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: patient inadvertently received a dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.     On 11-JAN-2021, the patient was inadvertently vaccinated as the patient's sibling had a very similar name with hepatitis a vaccine, inactivated(VAQTA) lot # T013205 with expiration date on 03-DEC-2021, 0.5 milliliter for prophylaxis (route of administration was not reported). There was no missed dose. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; Admisnistration of VARIVAX and PROQUAD at the same time.; This spontaneous report was received from a certified medical assistant and refers to a 1-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were provided.  On 08-JAN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (for both lot #, expiration date, route and site of administration were not provided) at the same time for prophylaxis (Overdose). The vaccines were reconstituted with sterile diluent (STERILE DILUENT) (dose, route of administration, lot # and expiration date were not provided). The reporter did not know, if there were any adverse event, however no additional adverse event was reported at that time. The outcome of the overdose was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experinced sore arm For 2nd dose refer case US2021000525. Did not consent to follow-up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000525:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine from vial which has been punctured for more than 6 hours; A spontaneous report (Un was received from a nurse concerning a 51-year old, female patient who received Moderna's COVID-19 Vaccine and experienced administered vaccine from vial which has been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered vaccine from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, lot # 026L20A.  There were no reported AEs associated with this case of expired product administered.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to a 17 years old; A spontaneous report was received from a rep concerning a 17-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate age at vaccine administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch 025J20-2A) and was administered vaccine to a 17 year old. The patient did not experience any symptoms. No treatment information was provided.   Action taken with mRNA-1273 in was not reported.  The outcome of the event, inappropriate age at vaccine administration, was resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Female patient 17 years of age received the vaccine; A spontaneous report  was received from a pharmacist concerning a 17-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced female patient 17 years of age received the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, approximately 0 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, a 17 year old female patient was administered the vaccine. No additional information was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The event, female patient 17 years of age received the vaccine, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: - hot at injection and upper arm. - itching - red (red circle) - swollen
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Dizziness, Dyspnoea, Epinephrine
Clinical narrative: Abdominal discomfort; Abdominal pain; Lightheaded/Dizzy; Having trouble taking deep breaths/couldn't breath; Sweating; Hyperventilating; Developed blotchy skin; Shaking; Headache; Vomited; A spontaneous report (United States) was received from a health care professional concerning a 50-year-old, female patient who received Moderna's COVID-19 vaccine and experienced abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited.   The patient's medical history included current conditions of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide. Concomitant products known to have been used by the patient, within two weeks prior to the event, included cefixime, ibuprofen, omeprazole, estradiol, and hydrocodone bitartrate, paracetamol.     On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) in their left arm for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient told a medical assistant in the waiting area that she felt ill to her stomach and she was having trouble taking deep breaths. The patient was found in a nearby bathroom sitting on the floor. She had vomited, reported she was lightheaded, couldn't breath, was shaking, had abdominal discomfort, and was sweating. It was attempted to move the patient to a wheelchair, but she did not respond well to the transfer. The patient reported the symptoms worsening: headache, abdominal pain, and developed blotch skin, hyperventilating, and was dizzy. A code blue was called and the patient was given a 0.5mg Epinephrine injection. The patient was sent to the emergency room. Treatment for the event included 0.5mg Epinepherine injection, famotidine, ondansetron HCl, prednisone 60mg, and lorazepam 1mg intravenously.   Action taken with mRNA-1273 in response to the events was not provided.  The events abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited were considered not resolved.; Reporter's Comments: This case concerns a 50 year old female patient with medical history of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide, who experienced events of Abdominal discomfort, Abdominal pain, Dizziness, Dyspnoea, Hyperhidrosis, Hyperventilation, Rash macular, Tremor, Headache, and Vomiting following their first of two planned doses of mRNA-1273 (Lot number: 011J20A). The patient was found ill in the waiting room after leaving clinic prior to completing 15 minute observation time. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.