chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Supine position, Vertigo
Clinical narrative: @1410 Pt was brought in to the observation room via wheelchair. Per report, pt became dizzy and weak post vaccination. Fluids and crackers provided. Pt tol PO intake well even though she has complains of nausea. Elevated feet up with a chair.    @1415 Pt stated that she still feels nauseated but is a bit better. Attempted to stand pt, unable to. Pt automatically sat down halfway standing her up d/t "room is spinning." Transferred pt to a gurney. Placed on supine position. No sob noted. No s/sx of distress noted. Resp even and unlabored.    @1420 Pt is feeling better. Instructed to drink a can of juice and water. Tol well. Dizziness is mild. Nausea slightly. Tolerated PO fluids.    @1430 Orthostatics VS supine 125/72 (89) 84 99% RA 18. VS sitting 134/82 (96) 111 99%RA 18 with slight dizziness. Encourage pt to finish all her PO fluids as tolerated. Pt stated that she was in school earlier today and has been busy with everything. Pt stated that she didn't have a chance of drinking water.    @1440 Finished all her fluids. Pt is feeling better. Pt stated that her dizzy and headache are mild. C/O weakness to legs. Encourage to move around legs and feet to increase circulation. C/O wanting to urinate.    @1445 Transferred to from the gurney. Pt able to stand up straight without any problems. Gait stable and able to transfer by herself. Escorted bu nurse and mother to the bathroom. Pt able to transfer from the wheelchair to commode well. Pt able to go to the bathroom herself. Gait stable. Voided x1.    @1450 Pt is confident on going home. Mother is confident and willing to take her home. PT is feeling better with some mild weakness to legs, very mild dizziness.  Instructed to follow up with Primary Doctor and go to the ED for worsening symptoms. Pt and mother verbalized understanding.  Made Dr aware of the situation and agreed with plan.    @1500 Wheeled patient to outside and to mother's car. Pt tolerated activity well.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Computerised tomogram normal, Dyspepsia, Echocardiogram normal
Clinical narrative: Acute Lacunar Stroke....Events that led up to the stroke....High Fever, 102.6, chills and aches that began five and half hours after the vaccine (4pm on Sunday 5/16)- on and off till Tuesday morning (5/18).  From 3am to 11am on Monday the 17th intense, unbearable and unrelenting heartburn.  Tuesday 5/18 menstrual cycle started 6 days early.  Wednesday night in the middle of the night woke up feeling like I was having a seizure but I was not sure at the time what was happening.  Thursday night odd headaches.  Friday morning awoke with a stroke.  Vision was distorted.  Unable to see or balance.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Gaze palsy, Headache, Lacunar stroke, Magnetic resonance imaging abnormal, Menstruation irregular
Clinical narrative: Acute Lacunar Stroke....Events that led up to the stroke....High Fever, 102.6, chills and aches that began five and half hours after the vaccine (4pm on Sunday 5/16)- on and off till Tuesday morning (5/18).  From 3am to 11am on Monday the 17th intense, unbearable and unrelenting heartburn.  Tuesday 5/18 menstrual cycle started 6 days early.  Wednesday night in the middle of the night woke up feeling like I was having a seizure but I was not sure at the time what was happening.  Thursday night odd headaches.  Friday morning awoke with a stroke.  Vision was distorted.  Unable to see or balance.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Metamorphopsia, Ophthalmological examination abnormal, Pain, Pyrexia, Retinal exudates
Clinical narrative: Acute Lacunar Stroke....Events that led up to the stroke....High Fever, 102.6, chills and aches that began five and half hours after the vaccine (4pm on Sunday 5/16)- on and off till Tuesday morning (5/18).  From 3am to 11am on Monday the 17th intense, unbearable and unrelenting heartburn.  Tuesday 5/18 menstrual cycle started 6 days early.  Wednesday night in the middle of the night woke up feeling like I was having a seizure but I was not sure at the time what was happening.  Thursday night odd headaches.  Friday morning awoke with a stroke.  Vision was distorted.  Unable to see or balance.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Acute Lacunar Stroke....Events that led up to the stroke....High Fever, 102.6, chills and aches that began five and half hours after the vaccine (4pm on Sunday 5/16)- on and off till Tuesday morning (5/18).  From 3am to 11am on Monday the 17th intense, unbearable and unrelenting heartburn.  Tuesday 5/18 menstrual cycle started 6 days early.  Wednesday night in the middle of the night woke up feeling like I was having a seizure but I was not sure at the time what was happening.  Thursday night odd headaches.  Friday morning awoke with a stroke.  Vision was distorted.  Unable to see or balance.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Skipped period for month of May, month of July with heavy flow and heavy symptomatic period occuring in June and August
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation delayed, Menstruation irregular
Clinical narrative: Period was 15 days late with no possibility of pregnancy and lasted twice the normal length. The next period came two weeks early and lasted twice the length typical. Multiple instances of spotting during menstrual cycles since second vaccination which has never happened before.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pain in extremity
Clinical narrative: Patient returned to pharmacy about 30 minutes after vaccination with complaint of minor pain in left forearm and being able to feel a mass in forearm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ear discomfort, Hypoacusis, Tinnitus
Clinical narrative: Ears popped simultaneously.  Had ear muff feeling for days, ringing and hissing in ears.  Saw primary who put me on a low dose of prednisone then ent.  The ear muffs went away and the hissing went away.  The ringing went away as well and all that remained was that everything sounded different in my left ear.  My hearing was checked and I have slightly diminished hearing in my left ear.  They said there was no way to tell if it was from the vaccine or if it was like that before.  That I should still get the 2nd vaccine and see them immediately if it comes back.   I got the 2nd vaccine and nothing immediately.  Still uncomfortable in my left ear, feel like pressure sometime, very very slight ringing here and there.  But nothing I can?t live with.   It?s been 2 months since I got the 2nd.  There was no immediate reaction.  But now, now it is awful!! Out of nowhere the ringing is constant, the pressure, the ear muff. It?s all back.  And it awful.  I can?t live like this.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal pain, Paraesthesia, Sciatica
Clinical narrative: Had sciatic pain in left butt. Has also been on right side. Started hours later and has continued intermittently. Have had numbness and tingling in all 4 extremities intermittently,  starting with the right foot and leg. All symptoms have continued daily.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise, Nausea, Pain
Clinical narrative: Nauseous; Loose stools; Sick ever since; Arm started hurting; Felt achey; Fatigue; A spontaneous report was received from a 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "sick ever since", arm started hurting, felt achey, fatigue, nauseous and loose stools.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 around 2pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, at 2 am, the patient stated that her arm started hurting, she felt achey, fatigue and thought nothing of it. She took paracetamol for the achiness.   On 25 Dec 2020, the patient started to feel nauseous, had loose stools and felt more fatigue. Treatment information was not provided.   On 28 Dec 2020, the patient took a "cold test" that came back negative.    On 29 Dec 2020, she still feels fatigued.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, "sick ever since", arm started hurting, felt achey, nauseous and loose stools, were unknown. The outcome of the event, fatigue, was not resolved.   The reporter did not provide an assessment 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Nauseous; Loose stools; Sick ever since; Arm started hurting; Felt achey; Fatigue; A spontaneous report was received from a 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "sick ever since", arm started hurting, felt achey, fatigue, nauseous and loose stools.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 around 2pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, at 2 am, the patient stated that her arm started hurting, she felt achey, fatigue and thought nothing of it. She took paracetamol for the achiness.   On 25 Dec 2020, the patient started to feel nauseous, had loose stools and felt more fatigue. Treatment information was not provided.   On 28 Dec 2020, the patient took a "cold test" that came back negative.    On 29 Dec 2020, she still feels fatigued.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, "sick ever since", arm started hurting, felt achey, nauseous and loose stools, were unknown. The outcome of the event, fatigue, was not resolved.   The reporter did not provide an assessment 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: PT FALSELY REPORTED THAT THEY HAVE NEVER HAD A COVID VACCINE SHOT BEFORE ON THEIR CONSENT FORM AND VERBALLY PRIOR TO RECEIVING THE SHOT. UPON BILLING INSURANCE, IT CAME TO OUR ATTENTION THAT PATIENT HAS ALREADY COMPLETED THE COVID DOSE SERIES IN JANUARY AND FEBRUARY 2021 AT ANOTHER PHARMACY.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Myalgia, Neck pain, Vasodilatation
Clinical narrative: Strong pain that ran to the neck, after the vaccine, pain all night haste now inflation in the veins, balls in the arm and neck muscle pain throughout the arm and neck and bruises in the arm.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Eyelid function disorder, Facial paralysis, Fine motor skill dysfunction, Movement disorder
Clinical narrative: Diagnosed with Bell's Palsy. Complete loss of motor skills and movement on left side of face. Unable to close left eye, unable to raise left eye brow,  zero lip movement. Overall, total loss of control over lower cranial facial nerve. Prescribed with anti-viral and steroid. Recovery at about 95% of movement on August 9th, 2021.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neurological examination
Clinical narrative: Diagnosed with Bell's Palsy. Complete loss of motor skills and movement on left side of face. Unable to close left eye, unable to raise left eye brow,  zero lip movement. Overall, total loss of control over lower cranial facial nerve. Prescribed with anti-viral and steroid. Recovery at about 95% of movement on August 9th, 2021.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Product preparation error, Wrong product administered
Clinical narrative: None stated.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Heart rate decreased, Loss of consciousness, Malaise, Nausea
Clinical narrative: PATIENT RECEIVED VACCINE AT ABOUT 409PM. FELT FINE STANDING UP AND HEADING TO WAITNG AREA. WHILE GIVING ANOTHER VACCINE TO DIFFERENT PATIENT, SAID PATIENT WALKED OVER STATING HES NOT FEELING WELL. TOLD TO HAVE A SEAT,LESS THAN A MINUTE AFTER CHECKED ON PATIENT AND HE STATED HE FELT NAUSEAOUS AND NEEDED A TRASH CAN. GRABBED TRASH HEADING BACK OVER ASKED IF PATIENT ALSO FELT DIZZY PROCEEDED TO GET WATER FOR PATIENT WHEN HE PASSED OUT OF CHAIR FACE FIRST ONTO FLOOR. YELLED FOR EMS TO BE CALLED AND PROCEEDED TO TURN PATIENT OVER. HE THEN BEGAN TO WAKE UP. HE SAID HE FELT BETTER AND WAS FULLY CONSCIOUS. CHECKED PULSE SEMI NORMAL HE LAID ON THE FLOOR FOR A LITTLE BIT LONGER THAN WANTED TO SIT IN CHAIR. EMS ARRIVED AND STATED HIS HEART RATE WAS LOWER THAN NORMAL AND TOOK HIM TO HOSPITAL
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: PT FALSELY REPORTED THAT THEY HAVE NEVER HAD A COVID VACCINE SHOT BEFORE ON THEIR CONSENT FORM AND VERBALLY PRIOR TO RECEIVING THE SHOT. UPON BILLING INSURANCE, IT CAME TO OUR ATTENTION THAT PATIENT HAS ALREADY COMPLETED THE COVID DOSE SERIES IN JANUARY AND FEBRUARY 2021 AT ANOTHER PHARMACY.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Electrocardiogram, Hemiplegia, Magnetic resonance imaging
Clinical narrative: Caller stated that patient had a stroke and is paralyzed on the left side of his body. He is getting a little feeling back in the left arm. He can move it, but he can not control it.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Caller stated that patient had a stroke and is paralyzed on the left side of his body. He is getting a little feeling back in the left arm. He can move it, but he can not control it.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Dyspnoea, Feeling hot, Hyperhidrosis
Clinical narrative: Feeling weak, stomach pain, difficulty breathing, warm to touch and sweating. treated by having patient lie down with legs elevated and given a sip of Gatorade.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Biopsy, Pruritus, Rash, Rash papular
Clinical narrative: I started getting raised itchy bumps that started on my left arm near my wrist and they finally went away, others appeared on various areas of my body. (I have pictures) They are still flaring up now, in August, 2021. The doctor prescribed Prednisone, Hydroxyzine for itching, Famotidine and Allegra. None of them stopped the flare ups. Hydroxyzine helps with the itch. Calamine lotion helps some, but not for long. My doctor has referred me to Dermatologist (NP).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: I started getting raised itchy bumps that started on my left arm near my wrist and they finally went away, others appeared on various areas of my body. (I have pictures) They are still flaring up now, in August, 2021. The doctor prescribed Prednisone, Hydroxyzine for itching, Famotidine and Allegra. None of them stopped the flare ups. Hydroxyzine helps with the itch. Calamine lotion helps some, but not for long. My doctor has referred me to Dermatologist (NP).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Blood test, Coronary arterial stent insertion, Echocardiogram, Electrocardiogram
Clinical narrative: Heart attack, STEMI mid LAD
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Percutaneous coronary intervention, X-ray
Clinical narrative: Heart attack, STEMI mid LAD
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Ear discomfort, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: About 30 minutes after first dose I felt a rush up my arm straight into my neck then started having neck pain. The pain was very bad for week and a half to where I could hardly turn my neck ( neck very stiff). The real bad pain has eased off but pain still exist today.  About a 1 hour after vaccine very high pitch ear ringing  started the ring was ridiculous the first two weeks and I still to this day have ringing off and on in my ears almost everyday even had stopped up ears ( like a ride to the mountains).  I also had some high up chest pains after the first two shots. The next day after the first shot was nauseous and body aches all over.  I did tell the Guy after first dose about side effects but he did not seem to care
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: About 30 minutes after first dose I felt a rush up my arm straight into my neck then started having neck pain. The pain was very bad for week and a half to where I could hardly turn my neck ( neck very stiff). The real bad pain has eased off but pain still exist today.  About a 1 hour after vaccine very high pitch ear ringing  started the ring was ridiculous the first two weeks and I still to this day have ringing off and on in my ears almost everyday even had stopped up ears ( like a ride to the mountains).  I also had some high up chest pains after the first two shots. The next day after the first shot was nauseous and body aches all over.  I did tell the Guy after first dose about side effects but he did not seem to care
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Hypoaesthesia oral, Limb discomfort, Musculoskeletal discomfort, Vaccination site mass
Clinical narrative: Knot on my arm; Knot is up the base of the neck, and shoulder; Knot is up the base of the neck, and shoulder; Lips are a little bit numb; Arm is really kind of still a little bit uncomfortable; Shoulder is puffed up on the right side where she got the injection; Bottom of her face feels odd; hurts down to her elbow; A spontaneous report was received from a consumer concerning a female patient who experienced a knot on my arm: vaccination site mass, knot that has moved up from her shoulder to her neck: musculoskeletal discomfort, lips are a little bit numb: hypoaesthesia oral, arm is really kind of still a little bit uncomfortable: limb discomfort, shoulder is puffed up on the right side where she got the injection: injection site swelling, bottom of her face feels odd: facial discomfort, and she hurts down to her elbow: injection site pain.  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On an unknown date in Dec 2020, approximately one week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection.  On an unknown day in Dec-2020 the patient developed a knot on her arm, a knot that has moved up from her shoulder to her neck, her lips were a little bit numb, her arm was uncomfortable, her shoulder was puffed up on the right side where she got the injection, the bottom of her face felt odd, and she hurt down to her elbow.  The events were treated with Tylenol, however she still had pain.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events were unknown.; Reporter's Comments: This case concerns a female of unknown age with NS unexpected vaccination site mass, musculoskeletal discomfort, limb discomfort, facial discomfort, hypoaesthesia oral and NS expected injection site swelling, injection site pain.  Event onset about 1 week after first dose mRNA-1273. Treated with Tylenol. Event outcomes unknown. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Knot on my arm; Knot is up the base of the neck, and shoulder; Knot is up the base of the neck, and shoulder; Lips are a little bit numb; Arm is really kind of still a little bit uncomfortable; Shoulder is puffed up on the right side where she got the injection; Bottom of her face feels odd; hurts down to her elbow; A spontaneous report was received from a consumer concerning a female patient who experienced a knot on my arm: vaccination site mass, knot that has moved up from her shoulder to her neck: musculoskeletal discomfort, lips are a little bit numb: hypoaesthesia oral, arm is really kind of still a little bit uncomfortable: limb discomfort, shoulder is puffed up on the right side where she got the injection: injection site swelling, bottom of her face feels odd: facial discomfort, and she hurts down to her elbow: injection site pain.  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On an unknown date in Dec 2020, approximately one week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection.  On an unknown day in Dec-2020 the patient developed a knot on her arm, a knot that has moved up from her shoulder to her neck, her lips were a little bit numb, her arm was uncomfortable, her shoulder was puffed up on the right side where she got the injection, the bottom of her face felt odd, and she hurt down to her elbow.  The events were treated with Tylenol, however she still had pain.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events were unknown.; Reporter's Comments: This case concerns a female of unknown age with NS unexpected vaccination site mass, musculoskeletal discomfort, limb discomfort, facial discomfort, hypoaesthesia oral and NS expected injection site swelling, injection site pain.  Event onset about 1 week after first dose mRNA-1273. Treated with Tylenol. Event outcomes unknown. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Pruritus
Clinical narrative: Patient received her second dose of Moderna vaccine, Lot number 12374008 at 1605. Approximately 5 minutes later she reported having "itching" to the extremity she was injected on. A small amount of hives around the site is noted. Lung sounds are clear. No stridor indicated. Dr informed. Verbal order for 10 mg of Cetirizine received at 1616, and administered to the patient. She tolerated this well.    VS stable 1615 152/77 97% on RA HR 69 Resp 16-18 Temp= 97.8F    Verbal order also obtained for Albuterol inhaler, and epinephrine.03 mg PRN anaphylaxis.    VS remain stable= 1625 BP= 151/79 P= 63 O2= 98% on RA Temp 97.8 Resp=16   Patient declines any further symptoms and states the, "itching is getting better."    Follow up VS 1635 BP= 130/78 HR= 64 O2= 98% on RA Resp= 14-16   Symptoms continue to improve. Rash is gone. Patient denies itching at site. Dr updated. He cleared the patient to go home. She passed the walking test. Lung sounds remained clear. No indication of stridor, patient able to swallow water well. Disposition, home.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: Patient experienced lightheadedness about 5 minutes following vaccination. Became warm and began sweating. Patient proceeded to faint for about 3 seconds and came to. Patient was slightly disorientated after fainting but soon recognized time and place. Patient placed his head in between his legs for several minutes. Patient rested in waiting area and was given water and peanut butter crackers. After a roughly 40 minute waiting period, patient felt okay to leave the premise.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed period. FYI:  no possibility of being pregnant- also have not missed a period or been late since teenager.  No sign of period symptoms. Getting concerned about fertility since I'm trying to get pregnant very soon.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pneumonitis, Productive cough, Rhinorrhoea
Clinical narrative: The client reported she developed "shortness of breath, a runny nose, phlegm, and a cough" 2 days after receiving the first COVID vaccine Pfizer. The client stated the symptoms lasted 4 days. The client denied any dizziness. The client has a history of asthma and uses an inhaler as needed. The client did seek care in the emergency department for her initial symptoms. The client states she was prescribed oral steroids and her inhaler medication was changed. The client was unsure of the medication names. The client stated she was diagnosed with lung inflammation. The client has no known allergies.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Hypopnoea, Pallor
Clinical narrative: shallow breathing, SOB, sweating, pale face
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Placental disorder
Clinical narrative: @1345 Pt with family walked in the room. Pt looked pale. About to check with pt, when mother directed pt to the trash can. Redirected pt back to sitting down and gave an emesis basin for safety. Pt was diaphoretic, really pale. Nonpharmalogical interventions provided to relieve nausea. Elevated feet. Fanned pt for cool air to face. Pt is started to get better.    @1355 Pt is starting to feel better. Color is starting to come back. Pt still feel nauseous but better to earlier. Encourage to take a couple of deep breaths and to continue to fan pt.    @1405 Pt denies feeling nauseous. C/O slightly dizzy. Encourage intake of fluids and food. Apple juices and crackers provided. Tolerated PO intake.    @1415 Pt denies any dizziness, nausea. Pt is feeling better. Skin WNL. Pt is moving around better. Pt stated that he is ready to go home.    @1418 VS sitting 120/67 (80) 94 100%. @1419 VS standing 124/70 (83) 97 100%. Denies dizziness. Trial ambulation done. Tol well. Asymptomatic. Talked to mother and sister re: pt. They feel confident in taking pt home. Instructed to follow up with PMD and to bring pt back to ED for worsening or new symptoms. Pt, mother and sister verbalized understanding.    @ 1420 Pt walked out of the clinic with family. Gait stable. No distress. Resp even and unlabored.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Joint swelling, Peripheral swelling
Clinical narrative: Moderate feet and ankle swelling (maybe calves also),  especially in right leg, with elevated blood pressure (173/101).  Still present  over 2 weeks later - again mostly on right side.  BP improved slightly.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, C-reactive protein, Condition aggravated, Fatigue, Laboratory test
Clinical narrative: Joint inflammation began on day 2 after the shot (COVID dose #1). I supported with daily acupuncture treatments as per rheumatologist advice, with gradual worsening of symptoms. By day 5 it was clear the inflammation was progressing and I curtailed the recommended medication hold on my biologic. By day 8 it was clear I was flaring with systemic inflammation, accompanied by fatigue. I did not do the medication hold for dose 2, per the rheumatologist; but did do the dose at the optimal 3 week interval.  The flare is continuing, now 2 months after it began. It is gradually decreasing in intensity. To be clear, this is after a 5 year very solid remission.  It is impossible to tease out whether the vaccine or the medication hold is the causative factor; but the hold was a requirement for the vaccine per my rheumatologist.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Rheumatoid arthritis
Clinical narrative: Joint inflammation began on day 2 after the shot (COVID dose #1). I supported with daily acupuncture treatments as per rheumatologist advice, with gradual worsening of symptoms. By day 5 it was clear the inflammation was progressing and I curtailed the recommended medication hold on my biologic. By day 8 it was clear I was flaring with systemic inflammation, accompanied by fatigue. I did not do the medication hold for dose 2, per the rheumatologist; but did do the dose at the optimal 3 week interval.  The flare is continuing, now 2 months after it began. It is gradually decreasing in intensity. To be clear, this is after a 5 year very solid remission.  It is impossible to tease out whether the vaccine or the medication hold is the causative factor; but the hold was a requirement for the vaccine per my rheumatologist.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Head discomfort, Headache, Memory impairment, Neck pain
Clinical narrative: Head feels heavy inside and have brain fog, forgetful, headaches atleast 4 times a week and causes base of head to hurt and neck- achy feeling. I take Aleve daily for this
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Head feels heavy inside and have brain fog, forgetful, headaches atleast 4 times a week and causes base of head to hurt and neck- achy feeling. I take Aleve daily for this
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: allergic reaction; A spontaneous report was received from pharmacist concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced allergic reaction.   The patient's medical history was not reported. Concomitant product use was unknown by the reporter.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: A25L20A) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced allergic reaction. The patient did not have any previous history of allergic reactions. Treatment information was unknown.   Action taken with mRNA-1273 in response to the event was unknown.   The event outcome for the event allergic reaction was unknown.   The reporter did not provide an assessment for the event allergic reaction.; 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, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Vertigo
Clinical narrative: Got Dizzy, Blood pressure Very high. June 3,2021 I felt Very Dizzy
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Coma, Confusional state, Death
Clinical narrative: 1 -2 days after the first dose he started getting confused . 3rd day we admitted him to the hospital . At one point they thought or were testing about his brain bleeding . Roughly after 4 days in the hopsital his body crashed he was in a coma and then died roughly 14 days after the injection on March 24, 2021. He died of an acute intracerebral hemorrhage which we were told he had a blood clot then stroke
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 1 -2 days after the first dose he started getting confused . 3rd day we admitted him to the hospital . At one point they thought or were testing about his brain bleeding . Roughly after 4 days in the hopsital his body crashed he was in a coma and then died roughly 14 days after the injection on March 24, 2021. He died of an acute intracerebral hemorrhage which we were told he had a blood clot then stroke
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Flushing, Injection site erythema, Injection site rash
Clinical narrative: PATIENT REPORTS DIZZINESS, FLUSHING / REDNESS ON FACE / ITCHY RASH ON FACE AND ON ARM AROUND THE INJECTION SITE.  PATIENT SAID SHE FELT FINE AND SHE LEFT THE STORE.  PHARMACIST CALLED PATIENT LATER AND SPOKE TO PATIENT.  PATIENT SAID THE REDNESS ON THE FACE IS GONE ALREADY.  ONLY HER ARM -THE INJECTION IS RED.  PATIENT CONSULTED AND KNOWS TO MONITOR FOR SIGNS OF ALLERGIC RXN AND WILL TAKE ANTIHISTAMINE IF NECESSARY.  PT WILL MONITOR AND GO TO ER IF START TO FEEL TIGHTNESS OF THROAT AND HAVE TROUBLE BREATHING.  AT THE END OF THE CONVERSATION ON THE PHONE, PATIENT SAID SHE FELT WELL AND WILL WAIT TO TAKE  ORAL ANTIHISTAMINE  AND WILL MONITOR HERSELF.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: PATIENT REPORTS DIZZINESS, FLUSHING / REDNESS ON FACE / ITCHY RASH ON FACE AND ON ARM AROUND THE INJECTION SITE.  PATIENT SAID SHE FELT FINE AND SHE LEFT THE STORE.  PHARMACIST CALLED PATIENT LATER AND SPOKE TO PATIENT.  PATIENT SAID THE REDNESS ON THE FACE IS GONE ALREADY.  ONLY HER ARM -THE INJECTION IS RED.  PATIENT CONSULTED AND KNOWS TO MONITOR FOR SIGNS OF ALLERGIC RXN AND WILL TAKE ANTIHISTAMINE IF NECESSARY.  PT WILL MONITOR AND GO TO ER IF START TO FEEL TIGHTNESS OF THROAT AND HAVE TROUBLE BREATHING.  AT THE END OF THE CONVERSATION ON THE PHONE, PATIENT SAID SHE FELT WELL AND WILL WAIT TO TAKE  ORAL ANTIHISTAMINE  AND WILL MONITOR HERSELF.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Muscle fatigue, Muscle spasms, Pyrexia
Clinical narrative: The night of the vaccine fever like symptoms started and lasted for several days. The more concerning symptoms were on day 3 when running my heart all of a sudden started beating really hard and fluttering causing me to stop and catch my breath. The ongoing issue from days 3-6 have been muscle fatigue in odd places such as forearms (no abnormal forearm exercises or excessive use). Simple tasks like cleaning pan causes forearms to seize up and feel over worked or cramped. Electrolyte drinks and other vitamins are also being taken with a health diet to eliminate potential for side effects.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test normal, Computerised tomogram abnormal, Nephrolithiasis, Ultrasound scan abnormal
Clinical narrative: I experienced extreme back pain and immediately made an appointment with my doctor. I was diagnosed with an 11mm kidney stone after a series of tests. I was scheduled for outpatient surgery to remove the kidney stone.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray abnormal
Clinical narrative: I experienced extreme back pain and immediately made an appointment with my doctor. I was diagnosed with an 11mm kidney stone after a series of tests. I was scheduled for outpatient surgery to remove the kidney stone.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Headache, Seizure, Trigeminal neuralgia
Clinical narrative: Severe trigeminal neuralgia type headaches lasting over several days. Had a history of them before but never so bad, usually mild and occasional. Also some diarrhea. Increased seizures in a person with seizure disorder.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Moderna was administered on day 22 instead of day 28. Patient was notified. Patient was not concerned and no adverse reactions have shown
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: PATIENT LIED  ON CONSENT FORM THAT THIS WAS THEIR FIRST COVID VACCINE, AND TO PHARMACIST AND CLERK WHO ASKED IF THIS WAS THEIR FIRST VACCINE.  ERROR WAS DISCOVERED DURING PROCESSING OF THE VACCINE PRESCRIPTION. WHEN PATIENT WAS CONTACTED, THEY ADMITTED THAT THEY HAD RECEIVED 2 DOSES OF PFIZER IN THE PAST.  THEY STATED THAT THEY HAD READ THAT THE CDC/DR. HAD RECOMMENDED BOOSTERS FOR IMMUNOCOMPROISED PEOPLE.  PATIENT STATED THAT THEY WERE IMMUNOCOMPROMISED DUE TO HAVING LYME DISEASE.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: Sore; Wanted to take Nap; A spontaneous report was received from a consumer, concerning a 63-year-old, female patient who who received Moderna's COVID-19 vaccine and experienced the events "wanted to take a nap" and "sore".   The patient's medical history included cystic fibrosis.  Concomitant product use was not provided by the reporter.   On 23-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Four hours after vaccine administration, the patient wanted to take a nap and was sore. Treatment information was not provided. The patient is scheduled to receive 2nd dose January 20. Patient   Action taken with mRNA-1273 in response to the events, wanted to take a nap and sore, was not provided.   The outcome of the events wanted to take a nap and sore was unknown.; Reporter's Comments: This spontaneous report concerning a 63-year-old, female patient with medical history of cystic fibrosis who experienced the event of "wanted to take a nap" and "sore. The event occurred on the same day, 4 hours after the administration of the first dose of mRNA-1273 (lot number unknown, expiration date unknown). No treatment information was provided, and outcome is Unknown.  Based on the current available information and temporal association between the use of the mRNA-1273 vaccine and onset of the reported events a causal relationship cannot be excluded.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted immediately after vaccination.  I was in the vaccination room with her and caught her head before it hit anything and supported her so she didn't fall out of the chair.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Excessive eye blinking, Facial paralysis, Facial spasm, Headache
Clinical narrative: 7/29 woke up with circle of red fine line and what looks like a scope on a firearm on my right arm. No broken skin or swelling 8/1 went to bed with extreme headache 8/2 woke up with headache, eyelids started to twitch at work for about an hour 8/3 woke up with headache, went to work, 3pm left eye started blinking uncontrollably and had spasms all over my face. by the time I went to the hospital, the right side of my face was paralized, they thought I had a stroke at first but the doctor thought it is Lyme and asked if I'd been in the yard, After coming home and getting no relief from the antibiotics, I found in the article April 27,2021 about facial paralysis from the covid shot. I truely believe its from the shot. I dd not have a tick on me.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegia
Clinical narrative: 7/29 woke up with circle of red fine line and what looks like a scope on a firearm on my right arm. No broken skin or swelling 8/1 went to bed with extreme headache 8/2 woke up with headache, eyelids started to twitch at work for about an hour 8/3 woke up with headache, went to work, 3pm left eye started blinking uncontrollably and had spasms all over my face. by the time I went to the hospital, the right side of my face was paralized, they thought I had a stroke at first but the doctor thought it is Lyme and asked if I'd been in the yard, After coming home and getting no relief from the antibiotics, I found in the article April 27,2021 about facial paralysis from the covid shot. I truely believe its from the shot. I dd not have a tick on me.
Age: 27.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Injection site rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Patient spoke to the pharmacist regarding  whether it was possible to have a delayed reaction to the vaccines she received a week prior and stated that she woke up that morning with a large, red itchy rash at the injection site that was becoming larger and itchier as the morning progressed. When pharmacist looked at rash around 11:15am, she observed a large raised rash that covered the patient's entire bicep area. Patient took 25mg  Benadryl tablet approximately 12:05pm to help with the itchiness. Pharmacist advised patient to contact her primary physician regarding the reaction. Patient showed pharmacist the rash again at 4:35pm and the rash area had decreased in radius but was still red and raised. Patient stated rash was no longer itchy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Aphthous ulcer, Condition aggravated
Clinical narrative: On 5/16/2021, I developed canker sores at the back of my mouth.  I'd never had them before.  I tried treating them on my own but ended up calling the doctor's office 5/20/21 for advice.  I was told to apply Campho Phenique to the sores and they resolved after about a week and a half. During the first week in July, I noticed I'd lost  all of the old growth on the sides of my head, near the front.  I've had alopecia for a little over 2 years due to stress but the hair was growing back.  The new growth on the top of the head was unaffected.  I will be seeing my dermatologist this week for this.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Pt was in  office to have ears flushed for wax build up and given hearing screen, after hearing screen, pt given covid vaccine. 1/2 hr after getting vaccine,  pt c/o of not feeling well and started to pass out while while standing at the check out counter, was grabbed by mom, and nurse, put in chair, given some water, then passed out while sitting in the chair, pox 97% ra, heart rate normal, transferred back to exam room, BP 95/63, given blow by O2, after 10 min not feeling well , ambulance was called, took about 20 min to arrive. Pt  started feeling better but not 100% sent ER for further evaluation, HER Attending notified of pt.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Pre-eclampsia (Delivered at 38 Weeks) and Alcohol use (Prior Use) in May 2020. Concurrent medical conditions included Sjogren's syndrome since 01-May-2014 and Gestational diabetes since December 2020. Concomitant products included METFORMIN from December 2020 to an unknown date for Gestational diabetes, IRON from November 2020 to an unknown date and VITAMIN D [VITAMIN D NOS] from 2020 to an unknown date for Supplementation therapy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (ASPIRIN 81) from June 2020 to an unknown date.    On 24-Dec-2020 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was Feb-2021. On 24-Dec-2020 at 4:00 PM, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). On 24-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) 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.   No treatment information was provided.; Reporter's Comments: This case concerns a 32 year-old, female patient, who is pregnant and experienced an event of vaccine exposure during pregnancy after receiving her first dose of mRNA-1273 vaccine. No adverse events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: A spontaneous report was received from a nurse concerning a 39 year-old, female patient participating in the mRNA-1273 Emergency Use Program and experienced a very swollen arm, pink circle around the site (of injection) the size of a half dollar, pain, low grade fever, and feeling tired.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient reported her arm being very swollen and painful with a pink circle around the site, the size of a half dollar. She also reported a low-grade fever (99.4F) and just feeling kind of tired.  Treatment for the event included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported.; 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, a causal relationship cannot be excluded.  The events of injection site erythema, injection site pain, pyrexia and fatigue are listed in CCDS.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Felt nauseas and has headache since she received the vaccine; Felt nauseas and has headache since she received the vaccine; A spontaneous report was received from a consumer concerning a 78-year-old female patient who received Moderna's COVID-19 vaccine and experienced the event "felt nauseas and has headache since she received the vaccine".  There were no medical history and concomitant medications reported.  On 29-Dec-2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29-Dec-2020 the patient developed nausea and a headache.    Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events "felt nauseas and has headache since she received the vaccine" was unknown.; Reporter's Comments: A spontaneous report concerns a 78-year-old female patient who experienced the non-serious event s of "felt nauseas and has headache since she received the vaccine". The events occurred on the same day after the administration of the first dose of mRNA-1273 (lot number unknown, expiration date unknown). Nausea and headache are consistent with the known safety profile of the mRNA-1273 vaccine and based on the current available information and temporal association between the use of the mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm is hurting; Arm is hard to bend; A spontaneous report was received from a consumer concerning a 29-year old, female patient who received Moderna's COVID-19 vaccine and experienced arm is hurting and arm is hard to bend.   There were no medical history and concomitant medications reported.  On 28 Dec 2020, approximately 6 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH # 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Dec 2020 at 6:30 pm, the patient reported experiencing pain in her left arm and difficulty bending the arm. This pain is located on the left arm in the middle muscle between area between the shoulder and elbow and right in the middle, per the patient, and was still ongoing at the time of report.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events arm is hurting, and arm is hard to bend, were unknown.; Reporter's Comments: This case concerns a 29-year old female who experienced nonserious events of arm is hurting and arm is hard to bend. The events occurred approximately 6 hours after she received the first of two planned doses of mRNA-1273 (Lot # 037K20A). The patient's past medical history and con meds were not provided. Very limited information regarding these events has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded. Additional information is required for further assessment.