chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pallor
Clinical narrative: erythematous blanching area about 10cm x 4 cm
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus in both ears
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium, Chest X-ray, Electrocardiogram, Electrocardiogram abnormal, Full blood count
Clinical narrative: Syncope event caused ER trip where abnormal ECG resulted with possible pericarditis
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Syncope, Troponin
Clinical narrative: Syncope event caused ER trip where abnormal ECG resulted with possible pericarditis
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Pericarditis, Syncope
Clinical narrative: Syncope event caused ER trip where abnormal ECG resulted with possible pericarditis
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN ARMS RADIATING FROM DELTOID DOWN TO FINGERTIPS; This spontaneous report received from a pharmacist concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced tingling in arms radiating from deltoid down to fingertips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in arms radiating from deltoid down to fingertips was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Vomiting
Clinical narrative: Resident reported feeling of throat "closing off" upon return to Nursing Home facility after receiving her second COVID-19 vaccine at Dr. office. Resident then vomited large amount of liquid. At that time resident denied any shortness of breath or difficulty breathing. Vital signs stable. Tylenol and Bendaryl ordered and given by Nursing Home Nurse Practitioner. Resident did not require higher level of care.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccine Administration Error
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Borrelia test, Fungal skin infection, Pyrexia, Rash
Clinical narrative: total body rash starting on lower back 5/28 and proceeding up back to scalp, around sides of body, around armpits, groin, under stomach fold, behind ear lobes. Mild to moderate itchiness. Bloomed to bright red on back. mild fever up about 2 degrees for me from my usual 97,2 to 99.6. Went to ER 5/31 and was held for 2 days while it was investigated. No infectious disease or blood diseases found. Treated at first with IV benedril and then prednesone with relief of itch and gradual fading of rash. some fungal infection found in skin folds and treated. Fever manifested mostly on first day. Sent home second day with script for prednesone, anti-fungal cream and pepcid. Rash gradually going away with current treatment. Final dx was rash reaction post JJ shot. .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination complication
Clinical narrative: total body rash starting on lower back 5/28 and proceeding up back to scalp, around sides of body, around armpits, groin, under stomach fold, behind ear lobes. Mild to moderate itchiness. Bloomed to bright red on back. mild fever up about 2 degrees for me from my usual 97,2 to 99.6. Went to ER 5/31 and was held for 2 days while it was investigated. No infectious disease or blood diseases found. Treated at first with IV benedril and then prednesone with relief of itch and gradual fading of rash. some fungal infection found in skin folds and treated. Fever manifested mostly on first day. Sent home second day with script for prednesone, anti-fungal cream and pepcid. Rash gradually going away with current treatment. Final dx was rash reaction post JJ shot. .
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: The patient stated that he became lightheaded and dizzy after taking his second vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: ADMINISTRATION ERROR; This spontaneous report received from a health care professional concerned patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patients received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: 20-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subjects experienced administration error. The action taken with covid-19 vaccine was not applicable. The outcome of administration error was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Atypical pneumonia, Back pain, Chest X-ray, Computerised tomogram thorax, Cough
Clinical narrative: I was okay for the first two weeks I went to the ER on 05-30-2021 due to cough, slight headaches, pain in my back. I came to find out the pain I was experiencing was "walking pneumonia".  At the ER x-rays of the chest, CT scan of the chest with contrast , UA were performed.  I was given albuterol inhaler and z-pack and Oxycodone for pain.  I still have bit of pain to my back and slight headaches that come and go.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urine analysis
Clinical narrative: I was okay for the first two weeks I went to the ER on 05-30-2021 due to cough, slight headaches, pain in my back. I came to find out the pain I was experiencing was "walking pneumonia".  At the ER x-rays of the chest, CT scan of the chest with contrast , UA were performed.  I was given albuterol inhaler and z-pack and Oxycodone for pain.  I still have bit of pain to my back and slight headaches that come and go.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache, nausea, light headed.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint noise, Joint range of motion decreased, Mobility decreased
Clinical narrative: Arm became severely sore after 90 minutes. Could not lift arm.  Shoulder area remains painful  with movement with pain radiating to neck/head at times.  Shoulder and upper arm has limited range of motion.  A "clicking" sensation occurs when moving in a circular motion.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Arm became severely sore after 90 minutes. Could not lift arm.  Shoulder area remains painful  with movement with pain radiating to neck/head at times.  Shoulder and upper arm has limited range of motion.  A "clicking" sensation occurs when moving in a circular motion.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Fatigue, Myasthenia gravis
Clinical narrative: Patient began having a myasthenia gravis exacerbation after the 1st vaccine. Then after the second vaccine it got a lot worse with fatigue/SOB, and weakness. Patient has not gained anything back.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF PUNCTURED VIAL  AFTER 6 HOURS; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: 01-AUG-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced administration of punctured vial after 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of punctured vial after 6 hours was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Post vaccine in waiting lot - Numbness, paresthesia to right arm/side. Negative for facial drooping, SOB, tachycardia, chest pain. A/O x3. Medical Hx of hypercholesterolemia, no other issues.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Chills, Crying, Fear
Clinical narrative: Coming close to 6 weeks with vertigo issues , I?m off balance , unsteady, shaky movement,  I haven?t had any progress of feeling better! I have anxiety and panic attacks, I have the chills in the morning. I?ve seen my PCP who prescribed me mcylzine , and a steroid taper pack ! Didnt really see and or feel any change ! So she referred me to an ENT , and he wants me to take nortriptyline , but I?m very cautious of taking a anti depressant! These events have brought great fear to me! I was perfectly normal before the vaccine! I would run everyday , workout and enjoy life! I haven?t been able to enjoy these things! Currently taking hydroxyzine for anxiety and high vitamin to get the inflammation done!  Must be a inner ear inflammation from the spike protein we think! I cry a lot , cuz I miss my life
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Panic attack, Tremor, Vertigo
Clinical narrative: Coming close to 6 weeks with vertigo issues , I?m off balance , unsteady, shaky movement,  I haven?t had any progress of feeling better! I have anxiety and panic attacks, I have the chills in the morning. I?ve seen my PCP who prescribed me mcylzine , and a steroid taper pack ! Didnt really see and or feel any change ! So she referred me to an ENT , and he wants me to take nortriptyline , but I?m very cautious of taking a anti depressant! These events have brought great fear to me! I was perfectly normal before the vaccine! I would run everyday , workout and enjoy life! I haven?t been able to enjoy these things! Currently taking hydroxyzine for anxiety and high vitamin to get the inflammation done!  Must be a inner ear inflammation from the spike protein we think! I cry a lot , cuz I miss my life
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine, treated with Tylenol, lasted 32 hours
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: asymptomatic testing
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm became warm and sore half an inch below injection site. A 2in x 2.5in red, raised rectangular, tender swollen area arose.  The affected area always remained below the injection site with only a light red mark that led from the injection site to the affected area.  The following morning (6/2/21) the area had more than doubled. It remained hard, warm, tender, and raised with swelling. It was mildly painful.     6/3/21 the red area had spread out over more of my bicep and the stiffness began to diminish slightly. It was still warm and slightly painful.  6/4/21 the swelling is down considerably and the redness has almost completely cleared. The area is still tender.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Arm became warm and sore half an inch below injection site. A 2in x 2.5in red, raised rectangular, tender swollen area arose.  The affected area always remained below the injection site with only a light red mark that led from the injection site to the affected area.  The following morning (6/2/21) the area had more than doubled. It remained hard, warm, tender, and raised with swelling. It was mildly painful.     6/3/21 the red area had spread out over more of my bicep and the stiffness began to diminish slightly. It was still warm and slightly painful.  6/4/21 the swelling is down considerably and the redness has almost completely cleared. The area is still tender.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Pruritus
Clinical narrative: Itching/prickly something burning sensation on hands and feet. Mainly hands.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS KEPT IN THE  FREEZER AFTER DELIVERY AND  THAWED OVERNIGHT AND KEPT IN  THE FRIDGE TILL VACCINATION; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination. On 30-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605028, 20210605010, 20210605120, 20210604703 and 20210605009.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Discomfort, Flatulence, Influenza like illness, Insomnia
Clinical narrative: Felt great @ post injection.  9pm took 2 Melatonin & drank small cup hot Sleepy Time tea..  Went to bed.  At 11:30 pm still not asleep.  Restless & uncomfortable.  1:40 am woke up with terrible whole body muscle aches, sore belly, flatulence, gas, migraine-like headache, C5 & C6 neck pain, occasional leg cramping.  Felt like I had the flu.  Got out of bed & sat in recliner with quilt over me.  After a bit started feeling a little better.  Went back to bed @ 3 am.  Still had a rough time getting back to sleep.  Very uncomfortable.  Got up @ 5am.  Still have intense total-body aches, neck pain, headache, fever 100.1      Drinking a lot of water.  Took 2 / 500mg Acetaminophen
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle spasms, Neck pain, Pain, Pyrexia
Clinical narrative: Felt great @ post injection.  9pm took 2 Melatonin & drank small cup hot Sleepy Time tea..  Went to bed.  At 11:30 pm still not asleep.  Restless & uncomfortable.  1:40 am woke up with terrible whole body muscle aches, sore belly, flatulence, gas, migraine-like headache, C5 & C6 neck pain, occasional leg cramping.  Felt like I had the flu.  Got out of bed & sat in recliner with quilt over me.  After a bit started feeling a little better.  Went back to bed @ 3 am.  Still had a rough time getting back to sleep.  Very uncomfortable.  Got up @ 5am.  Still have intense total-body aches, neck pain, headache, fever 100.1      Drinking a lot of water.  Took 2 / 500mg Acetaminophen
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: Felt great @ post injection.  9pm took 2 Melatonin & drank small cup hot Sleepy Time tea..  Went to bed.  At 11:30 pm still not asleep.  Restless & uncomfortable.  1:40 am woke up with terrible whole body muscle aches, sore belly, flatulence, gas, migraine-like headache, C5 & C6 neck pain, occasional leg cramping.  Felt like I had the flu.  Got out of bed & sat in recliner with quilt over me.  After a bit started feeling a little better.  Went back to bed @ 3 am.  Still had a rough time getting back to sleep.  Very uncomfortable.  Got up @ 5am.  Still have intense total-body aches, neck pain, headache, fever 100.1      Drinking a lot of water.  Took 2 / 500mg Acetaminophen
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriogram carotid, Balance disorder, Blindness unilateral, Cerebrovascular accident, Chest X-ray
Clinical narrative: April 20, 2021. PT needed to use the restroom.  We stopped, he walked to the restroom, I went to the gift shop. Upon returning, I saw PT sitting on a bench. He was leaning to his left, could not see out of his left eye, very unstable when sitting. We missed lunch, so we thought it was his sugar dropping. I started to feed him jam and a chocolate bar. After 2 hours, his vision returned & he seemed better. He drove us back to the rental cabin. He rested the next 2 days.  Then on Friday, we packed up our vehicle and Pt drove us back home. After arriving home, Pt's condition got worse. We went to the Dr, explained the events of the previous week & she came to the same conclusion, Diabetes spell. His condition continued to worsen, we went back to Dr several times, the ER 2 times and finally we got into see a Neurologist. That appointment, the doctor said he thought stroke. Dr scheduled a MRI for June 1, 2021. Results of that MRI was a definite stroke. Now he has started outpatient rehab with no promise he will ever regain full mobility. He can no longer drive, mow grass, walk without a cane and help, etc. Life has changed dramatically for both of us.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Hemiparesis, Impaired driving ability, Laboratory test, Magnetic resonance imaging head abnormal
Clinical narrative: April 20, 2021. PT needed to use the restroom.  We stopped, he walked to the restroom, I went to the gift shop. Upon returning, I saw PT sitting on a bench. He was leaning to his left, could not see out of his left eye, very unstable when sitting. We missed lunch, so we thought it was his sugar dropping. I started to feed him jam and a chocolate bar. After 2 hours, his vision returned & he seemed better. He drove us back to the rental cabin. He rested the next 2 days.  Then on Friday, we packed up our vehicle and Pt drove us back home. After arriving home, Pt's condition got worse. We went to the Dr, explained the events of the previous week & she came to the same conclusion, Diabetes spell. His condition continued to worsen, we went back to Dr several times, the ER 2 times and finally we got into see a Neurologist. That appointment, the doctor said he thought stroke. Dr scheduled a MRI for June 1, 2021. Results of that MRI was a definite stroke. Now he has started outpatient rehab with no promise he will ever regain full mobility. He can no longer drive, mow grass, walk without a cane and help, etc. Life has changed dramatically for both of us.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Quality of life decreased, Spinal X-ray, Walking aid user
Clinical narrative: April 20, 2021. PT needed to use the restroom.  We stopped, he walked to the restroom, I went to the gift shop. Upon returning, I saw PT sitting on a bench. He was leaning to his left, could not see out of his left eye, very unstable when sitting. We missed lunch, so we thought it was his sugar dropping. I started to feed him jam and a chocolate bar. After 2 hours, his vision returned & he seemed better. He drove us back to the rental cabin. He rested the next 2 days.  Then on Friday, we packed up our vehicle and Pt drove us back home. After arriving home, Pt's condition got worse. We went to the Dr, explained the events of the previous week & she came to the same conclusion, Diabetes spell. His condition continued to worsen, we went back to Dr several times, the ER 2 times and finally we got into see a Neurologist. That appointment, the doctor said he thought stroke. Dr scheduled a MRI for June 1, 2021. Results of that MRI was a definite stroke. Now he has started outpatient rehab with no promise he will ever regain full mobility. He can no longer drive, mow grass, walk without a cane and help, etc. Life has changed dramatically for both of us.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: Pt reports that she has had ongoing fatigue ever since her COVID Vaccines. Initially felt this as side effect from the first dose, didn't think much of it; Then after the second dose really started to notice that the ongoing fatigue was continuing, very low energy. Now continually feeling low energy, falling asleep more easily than ever before, even in the middle of the day.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: I did not have an ADVERSE event. I have had a LONG TERM POSITIVE event. There is no other way for me to report that I have had a significant lessening of my chronic Lyme symptoms. There is no other reason for this change other than having received the vaccine. I have had virtually no exercise induced fatigue and no joint or muscle pain, nor have I used Tylenol (at all) since my second vaccine. I hope that this can be reported to someone so that other patients who have auto immune or inflammatory issues might benefit.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Flank pain, Hypoaesthesia
Clinical narrative: Patient presented for second vocid-19 vaccine. after receiving vaccine, mother reported that patient had chest pain and grabbed chest and was experiencing leg numbness. Patient's parent reports that prior to receiving vaccine, aptietn has had history of one sided flank pain and tardive dsykinesia induced by medication. After vaccine mother reports patient is experiencing flank pain on opposite side. Mother wanting patient to be seen by provider so patient taken to hospital ED
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall, Pain, Pyrexia
Clinical narrative: ACHES; HAD A FALL; HAD A BRIGHT RED BRUISE; FEVER; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced aches. On 02-JUN-2021, the subject experienced had a fall. On 02-JUN-2021, the subject experienced had a bright red bruise. On 02-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: amoxicillin/clavulanic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, aches, had a fall, and had a bright red bruise. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: PATIENT EXPERIENCED SYNCOPE/DIZZINESS SHORTLY AFTER GETTING A SHOT
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient starting complaining of itchiness to entire body, given diphenhydramine HCL 25mg 1 tab PO at 2:00pm, checked vital signs when medication was administered and after 15 minutes stayed within normal limits, symptoms resolved within 20 minutes after medication administration, no other symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES/EVERYWHERE AROUND BODY; FEVER/EXTRA HIGH; VERY EXHAUSTED/EXHAUSTED AGAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 01-JUN-2021, the subject experienced very exhausted/exhausted again. On 03-JUN-2021, the subject experienced body aches/everywhere around body. On 03-JUN-2021, the subject experienced fever/extra high. Laboratory data included: Body temperature (NR: not provided) 101.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very exhausted/exhausted again, fever/extra high, and body aches/everywhere around body. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Energy increased, Insomnia
Clinical narrative: Patient said about 3 hours after taking the vaccine, he felt energized like he had taken multiple B12 shots. He has a sour stomach when he tries eating food. He was awake for 36 hours after the vaccine without any medication or caffeine. Patient stated the inflammation in his body from the gout, arthritis and lime disease is now gone. Patient hopes the reaction continues and hopes this will help his autism.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Prime dose administered 5/19/21.   Patient walked into clinic on 6/4/21 too early for booster and was administered booster in error.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient falsified DOB when registering for vaccination, stating the minor was one year older. Guardian consented to the vaccination. Health department verified with statistical records that the patients actual DOB is (what is now on file) which made the vaccine a contraindication.  No known adverse reactions noted.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Immediate pain upon injection.  As the days continued area became red, swollen, painful and got worse over the next 5-7 days.  Swelling and coloring has improved but pain and hard lump at injection site is still present.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Contraindication to vaccination, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient falsified DOB when registering for vaccination, stating the minor's DOB was (date given). Guardian, consented to the vaccination.  A state Department of Health verified with statistical records that the patients actual DOB is (date given) which made the vaccine a contraindication.  No known adverse reactions noted.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood glucose increased, Chills, Fatigue, Headache
Clinical narrative: Fever of 101.5, chills, -body aches, stomachache, headache, high blood sugars 400-500 for 24 hours, sore throat, tired, and sore muscles.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever of 101.5, chills, -body aches, stomachache, headache, high blood sugars 400-500 for 24 hours, sore throat, tired, and sore muscles.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Headache, Hypoaesthesia, Muscle spasms
Clinical narrative: TINGLING SENSATION OF FINGERS; MUSCLE CRAMPS; NUMBNESS ON BIG TOES ON LEFT SIDE; JOINTS PAIN; MILD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced tingling sensation of fingers. On MAY-2021, the subject experienced muscle cramps. On MAY-2021, the subject experienced numbness on big toes on left side. On MAY-2021, the subject experienced joints pain. On MAY-2021, the subject experienced mild headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation of fingers, mild headache, muscle cramps, joints pain, and numbness on big toes on left side. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING SENSATION OF FINGERS; MUSCLE CRAMPS; NUMBNESS ON BIG TOES ON LEFT SIDE; JOINTS PAIN; MILD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced tingling sensation of fingers. On MAY-2021, the subject experienced muscle cramps. On MAY-2021, the subject experienced numbness on big toes on left side. On MAY-2021, the subject experienced joints pain. On MAY-2021, the subject experienced mild headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation of fingers, mild headache, muscle cramps, joints pain, and numbness on big toes on left side. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Lethargy, Nausea, Pharyngeal swelling, Skin warm
Clinical narrative: throat swelling shut, called ambulance, took Benadryl. Currently nausea, burning lower stomach, severe lethargy, hot skin,
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Pain, Pyrexia
Clinical narrative: I FELT LIKE A TRAIN RAN ME OVER; BODY ACHE; FAST HEART RATE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced I felt like a train ran me over. On 03-JUN-2021, the subject experienced body ache. On 03-JUN-2021, the subject experienced fast heart rate. On 03-JUN-2021, the subject experienced headache. On 03-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, body ache, and fast heart rate, and the outcome of i felt like a train ran me over was not reported. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient falsified DOB when registering for vaccination, stating the minor was 07/13/2002. Guardian consented to the vaccination. Health department verified with statistical records that the patient's actual DOB is 07/13/2003 which made the vaccine a contraindication. No known adverse reactions noted.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore muscle at site of injection, recovered in 1 day
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS ADMINISTERED TO ONE PATIENT 15 HOURS AFTER THE VIAL WAS OPENED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced vaccine was administered to one subject 15 hours after the vial was opened. On 03-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered to one patient 15 hours after the vial was opened and incorrect product storage was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Data base says the patient received a vaccine on 4/20/21. We documented it in the patient chart. When the group home bought the patient in they said that he never received a vaccine.   Pt chart has that pt received 1st vaccine from pharmacy on 4/20/21. Pt received dose of Pfizer on 5/14/21 at Covid vaccine clinic. Pt received 2nd dose at Covid vaccine clinic today, 6/4/2021. Pt and caregiver state this is patients second dose and received first dose here on 5/14/2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Patient received the vaccine on 5/28/21 and called 6/4/21 because she developed a red rash around injection site today. She also stated that she feels itchy all over.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient falsified DOB when registering for vaccination. Guardian consented to the vaccination. Department of Health verified with statistical records the patients actual DOB which made the vaccine a contraindication.  No known adverse reactions noted.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: DOSE INJECTED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS/VACCINE VIAL WAS PUNCTURED YESTERDAY AND LEFT  OVER NIGHT IN THE FRIDGE; POOR QUALITY PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned a 23 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced dose injected outside of recommended storage conditions/vaccine vial was punctured yesterday and left over night in the fridge. On 03-JUN-2021, the subject experienced poor quality product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose injected outside of recommended storage conditions/vaccine vial was punctured yesterday and left over night in the fridge and poor quality product administered was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation
Clinical narrative: Patient developed burning, systemic rash (not raised) about 14 days after the vaccine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Moderna Covid-19 Vaccine EUA Injection SITE ROUND 6" INFLAMMATION , Hot and Raised.  painful, itching, some skin peeling. Reaction started within 24 hours and  side effects lasted 5-7 days. Other side effects not severe, fever 101 lasting 24 hours, treated with APAP. HA on and off for 7 days treated also with APAP slight runny nose and sore throat
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Skin exfoliation
Clinical narrative: Moderna Covid-19 Vaccine EUA Injection SITE ROUND 6" INFLAMMATION , Hot and Raised.  painful, itching, some skin peeling. Reaction started within 24 hours and  side effects lasted 5-7 days. Other side effects not severe, fever 101 lasting 24 hours, treated with APAP. HA on and off for 7 days treated also with APAP slight runny nose and sore throat
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received prime dose 5/18/2021  Walked into clinic too early for booster dose on 6/4/21 and received booster dose in error.
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Condition aggravated, Gait disturbance, Magnetic resonance imaging, Mobility decreased
Clinical narrative: she was limping; couldn't walk good; couldn't lift her leg, couldn't get in the bath tub; bursitis; She was continuing to get worse; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (she was limping; couldn't walk good) and MOBILITY DECREASED (couldn't lift her leg, couldn't get in the bath tub) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (she was limping; couldn't walk good) (seriousness criterion disability), MOBILITY DECREASED (couldn't lift her leg, couldn't get in the bath tub) (seriousness criterion disability), BURSITIS (bursitis) and CONDITION AGGRAVATED (She was continuing to get worse). The patient was treated with TRAMADOL at a dose of taken 6 in a day; MELOXICAM (MOBIC) at an unspecified dose and frequency; Physical therapy for Gait disturbance; Physical therapy for Mobility decreased and Physical therapy for Bursitis. At the time of the report, GAIT DISTURBANCE (she was limping; couldn't walk good), MOBILITY DECREASED (couldn't lift her leg, couldn't get in the bath tub), BURSITIS (bursitis) and CONDITION AGGRAVATED (She was continuing to get worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: inconclusive (Inconclusive) They did an MRI which showed no tear; hip joints look fine; doesn't need a hip replacement..         She was also prescribed anti-inflammatory Mobic which she said doesn't help her. No concomitant medications were reported.  Very limited information regarding these events have been provided at this time. No further information is expected.   This case was linked to MOD-2021-168279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Report content contained no new information.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Cerebral infarction, Facial paresis, Seizure
Clinical narrative: Cerebral infarction, unspecified; unspecified convulsions; facial weakness.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Blood test normal, Chills, Haematochezia
Clinical narrative: Lower abdomen cramping, nauseous, throwing up, chills, diarrhea, mucus bloody stools, bleeding rectally. Went to Hospital 3/29/2021. Given morphine. Stomach symptoms took a few days to go away. Still sample came back negative for Salmonella, Shigella, Aeromonas, Plesiomonas, isolated, No Campylobacter isolatea.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Mucous stools, Nausea, Rectal haemorrhage, Salmonella test negative, Vomiting
Clinical narrative: Lower abdomen cramping, nauseous, throwing up, chills, diarrhea, mucus bloody stools, bleeding rectally. Went to Hospital 3/29/2021. Given morphine. Stomach symptoms took a few days to go away. Still sample came back negative for Salmonella, Shigella, Aeromonas, Plesiomonas, isolated, No Campylobacter isolatea.
Sex: F
Vaccine: COVID19
Symptoms: Splenic infarction
Clinical narrative: Splenic infarct; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SPLENIC INFARCTION (Splenic infarct) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SPLENIC INFARCTION (Splenic infarct) (seriousness criterion medically significant). At the time of the report, SPLENIC INFARCTION (Splenic infarct) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included anticoagulants. No information was reported on treatment.  Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Headache, Vertigo, Vomiting
Clinical narrative: Severe headache 10 out of 10 started the following day with vertigo.  During this time he developed an episode of sudden onset double vision and vomiting which resolved after approximately 10 minutes.    The headache and the vertigo lasted for several days.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Facial paresis, Thrombocytopenia
Clinical narrative: Stroke determined by clinical assessment (CMS/HCC) Facial weakness Thrombocytopenia, unspecified
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Migraine
Clinical narrative: 1st shot - Mild reaction to first shot, itchy everywhere. 7mins after injection. Taken to ER (shot was down at local hospital) and given some antihistamines and felt fine afterwards.  2nd shot - No reaction right away like the first one, migraine for 2 days, went away. Main concern though is that my period is currently 2 weeks late after I received my second shot. I have taken multiple pregnancy tests and they all came back negative. Apparently a bunch of my friends have had the same side effect but they told me it comes back after a month. I?m surprise that this isn?t listed as one of the side effects of the vaccine. I was ready for the side effects listed but when I haven?t had my period I was worried and didn?t realize other women were having this side effect also.  I feel this should be told to women in order for them to prepare that this could be a side effect. Also it?s not just me, apparently there?s been a ton of woman about it on the internet talking about it and many of my personal friends have the same experience. Please be more open about side effects with women?s bodies.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Granuloma annulare, Skin lesion
Clinical narrative: I am not sure if this is a reaction to the vaccine or not, but thought perhaps it might be useful to you to report it in case you might be receiving other reports of the same.    I developed two small dark red spots, one on each thigh just above the knees.  I don't remember the exact date they appeared but it was definitely after receiving my second vaccine.  They did not itch or hurt and didn't go away after 3 months, so I went to the dermatologist to try and determine what they were.   The PA took a biopsy and the report came back they are granuloma annulare.   I researched online about them, and found out one cause could possibly be a correlation to vaccinations.  Any of the other possible cases do not pertain to me.    After my research, I realized they appeared after getting my second Covid vaccine and speculate that they could  be related, especially since I've never had it,  and further, I also had the Covid rash on my arm after the first dose.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Presyncope
Clinical narrative: patient had vasovagal reaction, blood pressure dropped 2-3 minutes post vaccine.  he was fine with first dose.  he had similar reaction with a meningococcal vaccine when he was 11.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Borrelia test negative, Dizziness, Fatigue, Headache
Clinical narrative: Headaches, dizziness, extreme fatigue, nausea and vomiting, rash similar to chickenpox, swollen lymph nodes, knee pain. Made a doctor's appointment and was tested for lyme's disease (negative result). Was told the side effects from the vaccine would wear off soon.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Rash, Vomiting
Clinical narrative: Headaches, dizziness, extreme fatigue, nausea and vomiting, rash similar to chickenpox, swollen lymph nodes, knee pain. Made a doctor's appointment and was tested for lyme's disease (negative result). Was told the side effects from the vaccine would wear off soon.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea
Clinical narrative: Headache Nausea Weakness
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood osmolarity decreased, Hyponatraemia, Seizure, Thrombocytopenia
Clinical narrative: Seizure; Acute kidney failure, unspecified; Hypo-osmolality and hyponatremia; Thrombocytopenia, unspecified
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (My husband is in the hospital with blood clits in the lungs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (My husband is in the hospital with blood clits in the lungs) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, PULMONARY EMBOLISM (My husband is in the hospital with blood clits in the lungs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received 2nd shot 7 days early.  No known adverse effect to the patient.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Sensory disturbance
Clinical narrative: Headaches, migraines, sensory issues.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Accute Tinnitus.  Started the morning after receiving the vaccine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant Ringing in my ears
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Client received Janssen vaccine on 4/7/2021 while incarcerated and again on 6/3/2021 while incarcerated.