chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: PATIENT GOT VACCINE ON 8/5/21 AND CAME ON 8/9/2021 TO PICK UP ANTI BIOTIC AND HAD CONVERSATION THEN FIND OUT ABOUT HER REACTION. SHE HAD SMALL BRUISE ON HER LEFT ARM AT INJECTION SITE, HER AREA OF VACCINATION IS SWALLON, RED AND HOT. SHE STARTED FEVER NEXT DAY, SHE STATED THAT SHE DID TOOK TYLENOL 500MG EVERY 6 HOURS TO HELP, BUT IT WAS ON AND OFF. SHE FELT LIKE ALLERGIC REACTION ALL OVER HER BODY AND HAVING ITCH AT INJECTION SITE AND OTHER AREAS OF  BODY. SHE WENT TO PRIMARY CARE DOCTOR TODAY, AND SHE WAS TOLD TO FINISH BACTRIM DS FOR 10 DAYS, BENDRYL AND TYLENOL UNTIL SYMTOMPS GETS BETTER.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or ACIP guidance.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives on right side of face and all over the body.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Disturbance in attention, Headache, Thinking abnormal, Visual impairment
Clinical narrative: I started having problems with my vision (difficulty seeing words).  I had a slight headache and then i had trouble thinking clearly.  I could not focus or find the right words as I was trying to speak.  The whole thing lasted 20-30 minutes, and the everything was fine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Chills, Dizziness, Dyspnoea, Feeling hot
Clinical narrative: Patient initially described not feeling well. She reported Dizziness, nausea,and painful breathing, shortness of breath, rapid heartbeat, feeling hot with shivers. One cold hand and one warm hand. vertigo, heavy eyes, tongue numbness no rash. Patient was offered and received 50mg Diphenhydramine as an oral suspension. As symptoms got worse, an epipen was administered to right outside thigh. Patient was given alcohol pad to self-swab before administration and a band aid to put on after epipen administration. Patient's symptoms improved dramatically within a couple minutes. Patient was picked up by sister and driven to primary physician after symptoms had largely cleared up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia oral, Malaise, Nausea, Painful respiration
Clinical narrative: Patient initially described not feeling well. She reported Dizziness, nausea,and painful breathing, shortness of breath, rapid heartbeat, feeling hot with shivers. One cold hand and one warm hand. vertigo, heavy eyes, tongue numbness no rash. Patient was offered and received 50mg Diphenhydramine as an oral suspension. As symptoms got worse, an epipen was administered to right outside thigh. Patient was given alcohol pad to self-swab before administration and a band aid to put on after epipen administration. Patient's symptoms improved dramatically within a couple minutes. Patient was picked up by sister and driven to primary physician after symptoms had largely cleared up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Vertigo
Clinical narrative: Patient initially described not feeling well. She reported Dizziness, nausea,and painful breathing, shortness of breath, rapid heartbeat, feeling hot with shivers. One cold hand and one warm hand. vertigo, heavy eyes, tongue numbness no rash. Patient was offered and received 50mg Diphenhydramine as an oral suspension. As symptoms got worse, an epipen was administered to right outside thigh. Patient was given alcohol pad to self-swab before administration and a band aid to put on after epipen administration. Patient's symptoms improved dramatically within a couple minutes. Patient was picked up by sister and driven to primary physician after symptoms had largely cleared up.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Chest pain, Hypertension
Clinical narrative: After 7 days after vaccine my blood pressure went up to 200 oscillating  during the week .I had to increase substantially my medication dose .  I had constant and prolonged chest pain . I had to see my cardiologist and I was treated with NITRO . I never had that kind of symptoms and high blood pressure before. Due to this symptoms I canceled my second dose of vaccine .
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Communication disorder, Confusional state, Dissociation, Irritability
Clinical narrative: Patient is 95 years.  Up until @2/12/2021 displayed no signs of "dementia" or confusion.  On or about 2/12/2021 she began to show signs of confusion, irritability and dissociation.  Her usual upbeat personal turned to sitting, looking down and choosing not to initiate conversation.  She responds to questions with minimal response.  Her memory seems to be mostly intact.  She occasionally makes negative comments about herself like "I'm so dirty", "I'm filthy".   I realize that my mother is 95 years old and that she is NOT in perfect health.  At this time she is not being treated for her condition and would likely refuse treatment.  IU offer this as information for your use.  Did the Vaccine trigger an episode?  Her doctor said :possibly".
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle came 2 weeks early after receiving second COVID-19 vaccine injection. My cycle is very regular and it is extremely rare to have my cycle begin early.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Seizure
Clinical narrative: new onset seizures
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numb and tingling right foot at bedtime. The next morning right foot was numb on the bottom outer area and pinky toe and the next two toes.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: Pt received Pfizer vaccine x2. Pt found to have COVID 8/7 after exposure to COVID + person. Admitted into the hospital. Pt remains on room air currently.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Pruritus
Clinical narrative: I HAVE TWO PIMPLES ON MY RIGHT ARM ABOUT THREE INCHES APART ON  7/26 AND TWO MORE ONE NEXT TO EACH OTHER ON THE LEFT ARM ON THE 27TH WHEN I WAKE UP. tHEY WERE ALSO ITCHING
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dyspepsia, Fear, Feeling abnormal
Clinical narrative: On February 13, 2021 was a Saturday. I never left my house that day. By early afternoon I felt completely fine but  I started having heartburn and it was bugging me alot. I took a prilosec. I continued my day. As the heartburn still wasnt going away about 8:30 PM I took a chewable tums. I again  I was going about my   business.   At about 12:30 AM now its 2/14/21  i was going to go to bed heartburn was still there so I drank some milk.  I went to bed, I feel asleep and 1 1/2 hours later I woke up feeling as somethings wrong I had a weird allergy type feeling  .Its hard to explain as I grabbed my phone and headed downstairs to take a benadryl. My husband was sleeping.  Within minutes I couldnt breathe at all. I couldnt get upstairs to my husband. I had to call 911. The EMS came and rushed me to medical center.  They let me know my pulse OX was 85% and BP was 200/160.  I only had minutes. This was extreme and I have never been so scared in my entire life.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Respiratory arrest
Clinical narrative: On February 13, 2021 was a Saturday. I never left my house that day. By early afternoon I felt completely fine but  I started having heartburn and it was bugging me alot. I took a prilosec. I continued my day. As the heartburn still wasnt going away about 8:30 PM I took a chewable tums. I again  I was going about my   business.   At about 12:30 AM now its 2/14/21  i was going to go to bed heartburn was still there so I drank some milk.  I went to bed, I feel asleep and 1 1/2 hours later I woke up feeling as somethings wrong I had a weird allergy type feeling  .Its hard to explain as I grabbed my phone and headed downstairs to take a benadryl. My husband was sleeping.  Within minutes I couldnt breathe at all. I couldnt get upstairs to my husband. I had to call 911. The EMS came and rushed me to medical center.  They let me know my pulse OX was 85% and BP was 200/160.  I only had minutes. This was extreme and I have never been so scared in my entire life.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body, Throat tightness
Clinical narrative: PATIENT WAITED THE 15 MINUTES FOR OBSERVATION AND LEFT AFTER THE RECOMMENDED TIME POST VACCINATION. AFTER LEAVING, PATIENT SAID THROAT STARTED CLOSING AND A BIG BUMP PRESENTED IN THE BACK OF HER THROAT. SHE TOOK BENADRYL IMMEDIATELY AND EMS WAS CALLED. SHE WAS FURTHER REFERRED TO AN URGENT CARE FACILITY AND WAS TREATED THERE.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Central venous catheterisation, Condition aggravated, Paralysis
Clinical narrative: Full body episodes of paralysis due to exacerbation of congenital periodic paralysis.  Initial time span of daily episodes of full body paralysis began April 6 and ended June 22 with several  ED visits and hospitalizations.  Beginning April 27, a PICC line was placed such that IV dextrose fluids could be administered at home instead of in the hospital.  During this time frame, some days an episode did not take place while other days 2 episodes happened. Between July 30 and August 4, 3 different fully body episodes occurred.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Urticaria
Clinical narrative: RASH AND HIVES
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest X-ray, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: Pericarditis R-reactive proteins elevated large amounts of palpitations SOB with and without activity chest pain
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Laboratory test, Palpitations, Pericarditis
Clinical narrative: Pericarditis R-reactive proteins elevated large amounts of palpitations SOB with and without activity chest pain
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: immediate hive at injection site
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: My period came a week early and had super painful cramps. I never get cramps and my period has always been at the same time frame between 1-2 days.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Patient reports approximately 1 week +/1 day after receiving her first Moderna COVID-19 vaccination she began to feel a tingling/numb sensation on her tongue. The following day when she awoke she had complete paralysis of one half of her face. Patient then went to see PCP where she was informed she had developed Bells Palsy. Patient is currently being treated with high dose steroids as well as valacyclovir.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis, Paraesthesia oral
Clinical narrative: Patient reports approximately 1 week +/1 day after receiving her first Moderna COVID-19 vaccination she began to feel a tingling/numb sensation on her tongue. The following day when she awoke she had complete paralysis of one half of her face. Patient then went to see PCP where she was informed she had developed Bells Palsy. Patient is currently being treated with high dose steroids as well as valacyclovir.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Blepharospasm, Diarrhoea, Hypersensitivity
Clinical narrative: Got shot 8/6/2021 @ 1:45pm.   At 2:30pm started itching- knew I was having an allergic reaction.  by 3:40pm called the pharmacy to report- itching was severe (worse) no hives.  was told to take 2 Benadryl. Took Benadryl- didn't work!   6 pm same day- ate some soup and took more Benadryl- was itching all over in my head and throughout my body to bottom of feet. 6:10 pm itching started calming down, then lower back right side started hurting, eyelids started twitching, face itching, and keep feeling like wanted to have diareha- had 2 BM's since having shot.  6:45pm - pain in right arm started at injection site, had dull muscle pain. Then left arm started aching.  8:30pm-  itching started back stronger and moderate stomach ache.  Did not sleep that night.  Sat. overall- still itching, not as severe, Right shot arm really hurting- did arm exercises and got better. stomach issues still there and itching.  itching FINALLY went away by Monday morning.  Sunday- by mid-late afternoon, I was really feeling unwell- started to go to hospital or urgent care- it was rough.  Prayed and toughed it out until could speak to my doctor on Monday- still unable to reach my Primary doctor- will see Allergy doctor  tomorrow- tues 8/10/21
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: Got shot 8/6/2021 @ 1:45pm.   At 2:30pm started itching- knew I was having an allergic reaction.  by 3:40pm called the pharmacy to report- itching was severe (worse) no hives.  was told to take 2 Benadryl. Took Benadryl- didn't work!   6 pm same day- ate some soup and took more Benadryl- was itching all over in my head and throughout my body to bottom of feet. 6:10 pm itching started calming down, then lower back right side started hurting, eyelids started twitching, face itching, and keep feeling like wanted to have diareha- had 2 BM's since having shot.  6:45pm - pain in right arm started at injection site, had dull muscle pain. Then left arm started aching.  8:30pm-  itching started back stronger and moderate stomach ache.  Did not sleep that night.  Sat. overall- still itching, not as severe, Right shot arm really hurting- did arm exercises and got better. stomach issues still there and itching.  itching FINALLY went away by Monday morning.  Sunday- by mid-late afternoon, I was really feeling unwell- started to go to hospital or urgent care- it was rough.  Prayed and toughed it out until could speak to my doctor on Monday- still unable to reach my Primary doctor- will see Allergy doctor  tomorrow- tues 8/10/21
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sleep deficit
Clinical narrative: Got shot 8/6/2021 @ 1:45pm.   At 2:30pm started itching- knew I was having an allergic reaction.  by 3:40pm called the pharmacy to report- itching was severe (worse) no hives.  was told to take 2 Benadryl. Took Benadryl- didn't work!   6 pm same day- ate some soup and took more Benadryl- was itching all over in my head and throughout my body to bottom of feet. 6:10 pm itching started calming down, then lower back right side started hurting, eyelids started twitching, face itching, and keep feeling like wanted to have diareha- had 2 BM's since having shot.  6:45pm - pain in right arm started at injection site, had dull muscle pain. Then left arm started aching.  8:30pm-  itching started back stronger and moderate stomach ache.  Did not sleep that night.  Sat. overall- still itching, not as severe, Right shot arm really hurting- did arm exercises and got better. stomach issues still there and itching.  itching FINALLY went away by Monday morning.  Sunday- by mid-late afternoon, I was really feeling unwell- started to go to hospital or urgent care- it was rough.  Prayed and toughed it out until could speak to my doctor on Monday- still unable to reach my Primary doctor- will see Allergy doctor  tomorrow- tues 8/10/21
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Eye inflammation, Hordeolum
Clinical narrative: Eye inflammation and stye 4 days following dose 1 and again,  4 days following dose 2.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted when standing to leave pharmacy after receiving vaccine.  Patient did wait suggested time of 15 minutes after receiving vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: continuous ringing in both ears (tinnitus)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Fatigue, Headache
Clinical narrative: Illness with severe headaches, weakness, fatigue, dizziness and nausea with exertion, sharp chest pain
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Illness with severe headaches, weakness, fatigue, dizziness and nausea with exertion, sharp chest pain
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Nauseous, body aches, bad headache, exhaustion.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor's recommendation.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Did good taking the shot,  passed out about a minute after it was administered was talking and in good spirits.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Loss of consciousness, Syncope
Clinical narrative: Did good taking the shot,  passed out about a minute after it was administered was talking and in good spirits.
Age: 0.33
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient fainted few seconds after receiving the vaccine. He was only unconscious for a few seconds.  Once patient was conscious was coherent.
Age: 0.33
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Loss of consciousness, Syncope
Clinical narrative: Patient fainted few seconds after receiving the vaccine. He was only unconscious for a few seconds.  Once patient was conscious was coherent.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Exposure to SARS-CoV-2, Oxygen therapy, SARS-CoV-2 test positive
Clinical narrative: Pt received Pfizer both doses. Admitted to the hospital on 8/7/2021 d/t generalized weakness. Pt was COVID positive d/t exposure. Pt did not require oxygen throughout admission
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or guidance.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Anxiety disorder, Blood test, Chest discomfort, Computerised tomogram abnormal
Clinical narrative: SHORTNESS OF BREATH AND TIGHTNESS OF CHEST.  1ST EMERGENCY ROOM VISIT PATIENT WAS SENT HOME DISAGNOSED WITH ANXIETY DISORDER. SOB AND TIGHTNESS CONTINUES DURING FOLLOWING WEEKS. PATIENT RETURNS FOR 2ND VISIT AT SAME EMERGENCY ROOM AT UNION HOSPITAL WITH SEVERE SHORTNESS OF BREATH. CAT SCAN OF LUNGS AND ULTRASOUND OF LEG REVEALLED MULTIPLE BLOOD CLOTS IN BOTH LUNGS AND BEHIND KNEE. PATIENT WAS ADMITTED TO HOSPITAL. PATIENT WAS PLACED ON IV BLOOD THINNERS DURING STAY. PATIENT WAS RELEASED ON ELIQUIS.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary thrombosis, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: SHORTNESS OF BREATH AND TIGHTNESS OF CHEST.  1ST EMERGENCY ROOM VISIT PATIENT WAS SENT HOME DISAGNOSED WITH ANXIETY DISORDER. SOB AND TIGHTNESS CONTINUES DURING FOLLOWING WEEKS. PATIENT RETURNS FOR 2ND VISIT AT SAME EMERGENCY ROOM AT UNION HOSPITAL WITH SEVERE SHORTNESS OF BREATH. CAT SCAN OF LUNGS AND ULTRASOUND OF LEG REVEALLED MULTIPLE BLOOD CLOTS IN BOTH LUNGS AND BEHIND KNEE. PATIENT WAS ADMITTED TO HOSPITAL. PATIENT WAS PLACED ON IV BLOOD THINNERS DURING STAY. PATIENT WAS RELEASED ON ELIQUIS.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone receptor positive breast cancer, Hot flush, Night sweats, Oestradiol increased
Clinical narrative: Hot flashes.  Currently on Tamoxifen (previously diagnosed with ER/PR+ breast cancer) and have not had hot flashes or night sweats for 2 years.  After the vaccine, started getting them again. Increased Estradiol.  Value for the last measurement (31Jan2020) prior to the vaccination was <11.8.  After having the hot flashes for a while, had the value tested and now the value is 610.4.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: red rash on arm which is spreading
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Retching
Clinical narrative: upon screening patient he informed that he had a fear of needles.   After the immunization was given patient felt like he was going to throw up.   Immediately got patient a waste back in case he was going to throw up.  Patient dry heaved once but never vomited.  Pt felt hot.   We attempted to give patient an ice pack but he requested a fan , we got a fan and that  helped.   Pt's dad was present so we asked dad to come in the room to comfort and sooth patient.  Pt requested water so we gave him a bottle of water.  We had patient sit for 25-30 minutes.  pt left without incident.   called pt this evening and he said he was feeling better, was a little nauseous the rest of the day but was able to eat lunch.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive Covid test post full vaccination
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Face injury, Fall
Clinical narrative: Patient had a dizzy spell and fell to ground from sitting position.  Patient skinned open a nickle sized cut on  right side of face. No other symptoms were reported. Patient continued to sit down for another 15 minutes under observation and left site afterwards. Patient refused medical treatment via ambulance. After sitting for the  additional 15 minutes, patient reported no other symptoms.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Swelling, Urticaria
Clinical narrative: Patient develop a welt immediately after receiving the vaccine. The swelling of the welt decreased in about 15 minutes.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or ACIP guidance.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hallucination, Induration, Malaise, Paraesthesia
Clinical narrative: Localized redness and swelling along with hard hot arm within 24 hours.  Fever 100-102.3 for 4-5 days along with hallucinations and mailaise which lasted several beyond the fever.  Arm itched, throbbed, and felt like was alseep for 2 weeks.  My left hand had less feeling in it for several months.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Sensory loss, Skin warm
Clinical narrative: Localized redness and swelling along with hard hot arm within 24 hours.  Fever 100-102.3 for 4-5 days along with hallucinations and mailaise which lasted several beyond the fever.  Arm itched, throbbed, and felt like was alseep for 2 weeks.  My left hand had less feeling in it for several months.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Mental disorder, SARS-CoV-2 test positive
Clinical narrative: Pt received pfizer x2 doses. Admitted to the hospital for AMS and was COVID+. Received one dose of remdesivir then went to room air. So no further remdesivir given . 3 doses of dexamethasone 6mg daily given inpatient.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna as first dose accidentally as a 16 year old (off-label). We administered Moderna as second dose due to guidelines from the CDC website (off-label).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Pt was having a syncope episode about 5 minutes after the vaccination. Mother states that he hates needles.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain, Pain in extremity
Clinical narrative: Migraine headache for 3 to 4 days, extreme pain in my arm from my shoulder down to my fingers.  Hot intense burning pain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injected limb mobility decreased, Lymph node pain, Lymphadenopathy, Migraine
Clinical narrative: The client reported that she developed dizziness 24 hours after the vaccine which lasted 6-7 days. The client also reported development of left axillary lymph node swelling and pain that lasted one week. The client states the pain caused her to be unable to lift her left arm. The client reported development of itchiness in her throat and chest 1-2 days after the vaccine that is still present. Lastly, the client reported onset of a migraine 1-2 days after the vaccine which lasted 5 days. The client took Maxalt for the Migraine. The client has taken Claritin each night, but states this has provided no significant relief of her throat and chest itchiness. The client has not followed up with a PCPC or allergist. The client has a history of a hysterectomy 2.5 months ago and has had constant shortness of breath since. The client has seen her doctor regarding the shortness of breath without any conclusion on the cause of relief. The client takes oral birth control medication. She has a history of allergies to Tetracycline, Ciprofloxacin, and Toradol. The allergic reaction to these medications consists of nausea and vomiting.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation
Clinical narrative: The client reported that she developed dizziness 24 hours after the vaccine which lasted 6-7 days. The client also reported development of left axillary lymph node swelling and pain that lasted one week. The client states the pain caused her to be unable to lift her left arm. The client reported development of itchiness in her throat and chest 1-2 days after the vaccine that is still present. Lastly, the client reported onset of a migraine 1-2 days after the vaccine which lasted 5 days. The client took Maxalt for the Migraine. The client has taken Claritin each night, but states this has provided no significant relief of her throat and chest itchiness. The client has not followed up with a PCPC or allergist. The client has a history of a hysterectomy 2.5 months ago and has had constant shortness of breath since. The client has seen her doctor regarding the shortness of breath without any conclusion on the cause of relief. The client takes oral birth control medication. She has a history of allergies to Tetracycline, Ciprofloxacin, and Toradol. The allergic reaction to these medications consists of nausea and vomiting.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy
Clinical narrative: Due date 10/31/21.  Second pregnancy.  first pregnancy healthy
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Adverse event, Eye swelling, Myalgia, Nausea
Clinical narrative: Around 9 PM the day I received the vaccine, the unexpected/adverse affect I experienced  was sudden swelling of my face, specifically my eyes (I do not have any dermal fillers just FYI).  It was accompanied by expected side effects including fever, muscle aches and nausea. I also experienced shooting pain throughout my body, but mostly in my arms, and my skin was painful to touch anywhere on my body.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain of skin, Pyrexia, Swelling face
Clinical narrative: Around 9 PM the day I received the vaccine, the unexpected/adverse affect I experienced  was sudden swelling of my face, specifically my eyes (I do not have any dermal fillers just FYI).  It was accompanied by expected side effects including fever, muscle aches and nausea. I also experienced shooting pain throughout my body, but mostly in my arms, and my skin was painful to touch anywhere on my body.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101 when going to bed. Took 200mg of ibuprofen. Fever of 103 when waking up. Took 200mg of ibuprofen.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Patient was vaccinated with first shot of Pfizer, he was previously vaccinated with both doses of Moderna back in March.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles one week to the day post second dose of Pfizer Covid 19 Vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction currently. Patient asked to monitor. Accidentally given 3rd dose of pfizer vaccine
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dysarthria, Eye haemorrhage, Movement disorder, Pain
Clinical narrative: Intense body aches, fever, inability to move, constant throwing up, inability to keep down food or water, popped blood vessels in eyes, swollen face,  slurred speech and extreme dehydration
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Vomiting
Clinical narrative: Intense body aches, fever, inability to move, constant throwing up, inability to keep down food or water, popped blood vessels in eyes, swollen face,  slurred speech and extreme dehydration
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic respiratory failure, Transient ischaemic attack
Clinical narrative: Pt received Moderna x2. Pt admitted on 8/8 for stroke code. Found to be TIA. Pt did receive a dose of remdesivir and dexamethasone as desaturated on RA. Found that pt has chronic respiratory failure and on chronic O2, so remdesivir and dexamethasone stopped.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, migraines
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Fall, Head injury, Headache
Clinical narrative: Headache, dizziness, fainting, profusely sweating about 19 hours after vaccine was administered. Patient experienced multiple fainting episodes, with elevated heart rate.  During the fainting episodes, the patient fell twice and hit his head twice.  He was briefly unresponsive.  He was taken by ambulance to the ER where he was given fluids and  X-RAY, CT Scan and lab work was done. Patient was released with instructions to follow up with primary care physician.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Laboratory test, Syncope, Unresponsive to stimuli
Clinical narrative: Headache, dizziness, fainting, profusely sweating about 19 hours after vaccine was administered. Patient experienced multiple fainting episodes, with elevated heart rate.  During the fainting episodes, the patient fell twice and hit his head twice.  He was briefly unresponsive.  He was taken by ambulance to the ER where he was given fluids and  X-RAY, CT Scan and lab work was done. Patient was released with instructions to follow up with primary care physician.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Headache, dizziness, fainting, profusely sweating about 19 hours after vaccine was administered. Patient experienced multiple fainting episodes, with elevated heart rate.  During the fainting episodes, the patient fell twice and hit his head twice.  He was briefly unresponsive.  He was taken by ambulance to the ER where he was given fluids and  X-RAY, CT Scan and lab work was done. Patient was released with instructions to follow up with primary care physician.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Autopsy, Cardiac arrest, Death
Clinical narrative: Pt died on April 15, 2021 of cardiac arrest.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: I have developed acne on my right cheek and face chin
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling; Pain in the arm; Heat in arm; Itching/it was not hot to touch but was itchy; Redness, local/a 2- 2.5 inch red area on her arm at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS, VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included SYNTHROID for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS and VACCINATION SITE ERYTHEMA. On an unknown date, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN outcome was unknown and VACCINATION SITE PRURITUS and VACCINATION SITE ERYTHEMA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information updated, onset date and outcome of the events updated. Sender's Comments: This case concerns a 72-year-old patient of unknown gender who had nonserious events of unexpected injection site warmth and expected erythema, injection site pain, injection site pruritus, injection site swelling. Event onset occurred with unknown latency after the first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Injection site pain, Pain
Clinical narrative: Body aches; Shaking; Sore arm; Fever of 102.6F; Headache; Chills; A spontaneous report, was received from a nurse, concerning a 38 year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced body aches (pain), sore arm (injection site pain), shaking (tremor), fever 102.6 (pyrexia), headache, and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K29A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 30 Dec 2020, at about 9 am, the patient experienced shaking, chills, fever 102.6, headache, body aches, and sore arm. Treatment for the events included acetaminophen and ibuprofen and fever got subsided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event, fever 102.6, was considered resolved on 31 Dec 2020. The outcome for the events, shaking, chills, headache, body aches, and sore arm, were not reported.; Reporter's Comments: This case concerns a 70-year-old female who experienced nonserious events of unexpected tremor and pain and expected injection site pain, fever, chills, headache. Event onset occurred the same day as the first dose of mRNA-1273. Treated with acetaminophen. Fever resolved, but other outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Body aches; Shaking; Sore arm; Fever of 102.6F; Headache; Chills; A spontaneous report, was received from a nurse, concerning a 38 year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced body aches (pain), sore arm (injection site pain), shaking (tremor), fever 102.6 (pyrexia), headache, and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K29A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 30 Dec 2020, at about 9 am, the patient experienced shaking, chills, fever 102.6, headache, body aches, and sore arm. Treatment for the events included acetaminophen and ibuprofen and fever got subsided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event, fever 102.6, was considered resolved on 31 Dec 2020. The outcome for the events, shaking, chills, headache, body aches, and sore arm, were not reported.; Reporter's Comments: This case concerns a 70-year-old female who experienced nonserious events of unexpected tremor and pain and expected injection site pain, fever, chills, headache. Event onset occurred the same day as the first dose of mRNA-1273. Treated with acetaminophen. Fever resolved, but other outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus
Clinical narrative: Itchy everywhere but not a rash; I don't have any severe allergic reaction; A spontaneous repor was received from a consumer who is 66-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a reaction like allergy stating she was itchy everywhere.   The patient's medical history included allergy to thimerosal. Concomitant medications included were vitamin D, calcium gluconate, amlodipine, vitamin B12, and vitamin E.   On 28-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, after administration, the patient stated that she was experiencing a reaction similar to when she took "ethanol diamine" medication. She stated she is sure she's not having a severe allergic reaction, she is just "itchy everywhere", but there is no rash. The patient was treated with betamethasone dipropionate cream, timolol maleate, coal tar and hydroxyzine.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, itchy everywhere, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of generalized pruitus a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Patient is pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 35-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Melanoma in October 2013 and Spontaneous abortion on 24-Nov-2018. Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Nov-2020 and the estimated date of delivery was 19-Aug-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 23-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This is a case of product exposure during pregnancy with no associated AE's for this 35 year old female. Patient will continue to be contacted for further monitoring of AE's during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AE's for this 35 year old female. Patient will continue to be contacted for further monitoring of AE's during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: neck pain/neck sore; headache; A report was received from a consumer who was also a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neck pain/neck sore and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experiencing neck pain/neck sore and headache.   Treatment for the event included paracetamol and the symptoms subsided, but then returned.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, neck pain/neck sore and headache were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia oral, Paraesthesia, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Hypersensitivity reaction; injection site hard; injection site hot; injection site itchy; tingling in face, shoulder, arm; whole face and tongue was numb; A spontaneous  report was received from a physician concerning a 38-year-old, female patient who experienced hypersensitivity reaction, injection site hardness, warmth, itching, numbing and tingling of the shoulder, arm and face, and whole face and tongue was numb following their first dose of Moderna's COVID-19 vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch number unknown) in the left arm for prophylaxis of COVID-19 infection.   The patient stated that eight days after the vaccination, her injection site became hard, hot and itchy. This started to resolve 48 hours later but lasted for two weeks.  She also experienced numbness and tingling of her face, shoulder and arm.  Her whole face and tongue were numb.   Treatments of these events included Benadryl and ice.    The events, hypersensitivity reaction, injection site hardness, warmth, itching, numbing and tingling of the shoulder, arm and face, and whole face and tongue was numb were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Hypersensitivity reaction; injection site hard; injection site hot; injection site itchy; tingling in face, shoulder, arm; whole face and tongue was numb; A spontaneous  report was received from a physician concerning a 38-year-old, female patient who experienced hypersensitivity reaction, injection site hardness, warmth, itching, numbing and tingling of the shoulder, arm and face, and whole face and tongue was numb following their first dose of Moderna's COVID-19 vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch number unknown) in the left arm for prophylaxis of COVID-19 infection.   The patient stated that eight days after the vaccination, her injection site became hard, hot and itchy. This started to resolve 48 hours later but lasted for two weeks.  She also experienced numbness and tingling of her face, shoulder and arm.  Her whole face and tongue were numb.   Treatments of these events included Benadryl and ice.    The events, hypersensitivity reaction, injection site hardness, warmth, itching, numbing and tingling of the shoulder, arm and face, and whole face and tongue was numb were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: dry heaves; arm hurting; muscle pain; joint pain; fever; chills; nausea; Headache; A spontaneous report was received from a Other Health Professional concerning a 45-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed muscle pain, joint pain, fever, chills, arm hurting, nausea, dry heaves, and headache.   The patient's medical history, included positive COVID-19 test in Nov 2020. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.   28 Dec 2020 the patient experienced fever of 99.4 to 99.6 joint pain, muscle pain, and her skin hurt. The patient also experienced dry heaves, nausea, and headache.   At the time of the report on 07 Jan 2021 the events had resolved.  Treatment of the events included Tylenol every four hours.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events muscle pain, joint pain, fever, chills, arm hurting, nausea, dry heaves, and headache were recovered.  Reporter causality for the events was not provided.  Additional information received on 07 Jan 2021 included units for fever and date of outcome for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.