chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash erythematous, Rash pruritic, Scar
Clinical narrative: I had 100 degree temperature for two days.  But a month later I started to have rashes on my upper armes n my legs. N they went away. N again about month later a few bumps came up n this time I felt dizzy for a few days. N they went away. N this month which about a month later a few bumps appeared and  not feeling well. I dealt with headache with bumps. Bumps are usually itchy n burning feeling, even I don't scratch them. They are red or pink. N scars won't go away.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Postural orthostatic tachycardia syndrome, Tilt table test, Ultrasound Doppler
Clinical narrative: I was diagnosed with POTS syndrome after multiple episodes of passing out and regular bouts of lightheadedness. The first episode was 2 days after my first COVID vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid  outbreak 11/24/2022 prescribed inhaler for cough
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Fatigue, Headache, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Headache x3 weeks treated with OTC Tylenol 1,000mg BID, Fatigue x5 days, Irregular menses x 3 periods with heavy bleeding x1 period (7 days) starting  11/18/2022 to 11/25/2022, second episode  12/2/102022, and third episode 12/23/2022 treated with rest, intermittent chest pain episodes lasting 3-14 hours at rest 11/18/2022 to present 1/13/2022 treated with baby aspirin x3 doses and rest.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Immobile, Laboratory test, Malaise, Pyrexia
Clinical narrative: My mother in law had a stroke 20 days after her second dose of her moderna vaccination, she was laid up so sick with a fever for the following 24 hours post vaccine and then suffered a major stroke 20 days later, her left side is completely immobile.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Insomnia, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I received my 4th dose of Pfizer Bivalent Booster on 09/24/2022. After 1 month of my COVID-19 vaccine I got a cold. My cold symptoms started on 10/27/2022 in the morning as soon as I woke up at 8:00AM. I had severe sore throat for 2 days straight, chills, nasal congestions and cough. My sore throat changed to a minor sore throat. I did a telehealth with my doctor on 11/02/2022. He prescribed me with benzonatate. I had thick phlegm cough that lasted for 8 weeks. I was very congested. It was hard for to sleep because of the cough which occurred continuously. I never had this before. As of today I am completely recovered.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Productive cough, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: I received my 4th dose of Pfizer Bivalent Booster on 09/24/2022. After 1 month of my COVID-19 vaccine I got a cold. My cold symptoms started on 10/27/2022 in the morning as soon as I woke up at 8:00AM. I had severe sore throat for 2 days straight, chills, nasal congestions and cough. My sore throat changed to a minor sore throat. I did a telehealth with my doctor on 11/02/2022. He prescribed me with benzonatate. I had thick phlegm cough that lasted for 8 weeks. I was very congested. It was hard for to sleep because of the cough which occurred continuously. I never had this before. As of today I am completely recovered.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Echocardiogram, Transient ischaemic attack
Clinical narrative: Had a TIA (transient ischemic attack)
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given product past stability period once punctured  (vial had been previously punctured  approximately 24 hours earlier)   Pt did not report adverse reactions.
Age: 12.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the wrong age Pfizer 5-11yr bivalent lot GK1657 exp 01/31/24, and the patient is 12 years old.  we went ahead and gave him the 12 yr booster GJ3270 exp 01/31/24 for his age. Guardian was ok with getting the vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram head abnormal, Dizziness, Dysarthria
Clinical narrative: Stroke.  Tuesday Sept 13, 2021 had bad headache, bad enougj couldn?t work. Wednesday very tired, slept all day and still had headache.  Took Covid test it was negative,  Sept 15 and 16 had ringing in ear and dizzy, took another Covid test and it was negative, Saturday dizzy and slurring. Went to hospital and found out had a stroke. Had additional stroke in the hospital. Was in the hospital 6 weeks. Couldn?t walk, could barely talk, couldn?t swallow and had a stomach tube.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Gait inability, Gastrostomy, Headache
Clinical narrative: Stroke.  Tuesday Sept 13, 2021 had bad headache, bad enougj couldn?t work. Wednesday very tired, slept all day and still had headache.  Took Covid test it was negative,  Sept 15 and 16 had ringing in ear and dizzy, took another Covid test and it was negative, Saturday dizzy and slurring. Went to hospital and found out had a stroke. Had additional stroke in the hospital. Was in the hospital 6 weeks. Couldn?t walk, could barely talk, couldn?t swallow and had a stomach tube.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Impaired work ability, Magnetic resonance imaging head abnormal, SARS-CoV-2 test negative, Speech disorder
Clinical narrative: Stroke.  Tuesday Sept 13, 2021 had bad headache, bad enougj couldn?t work. Wednesday very tired, slept all day and still had headache.  Took Covid test it was negative,  Sept 15 and 16 had ringing in ear and dizzy, took another Covid test and it was negative, Saturday dizzy and slurring. Went to hospital and found out had a stroke. Had additional stroke in the hospital. Was in the hospital 6 weeks. Couldn?t walk, could barely talk, couldn?t swallow and had a stomach tube.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Stroke.  Tuesday Sept 13, 2021 had bad headache, bad enougj couldn?t work. Wednesday very tired, slept all day and still had headache.  Took Covid test it was negative,  Sept 15 and 16 had ringing in ear and dizzy, took another Covid test and it was negative, Saturday dizzy and slurring. Went to hospital and found out had a stroke. Had additional stroke in the hospital. Was in the hospital 6 weeks. Couldn?t walk, could barely talk, couldn?t swallow and had a stomach tube.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Product packaging confusion
Clinical narrative: Pt was given original formulation product rather than the bivalent product.   Look-alike vials cited as contributing factor.   Pt did not report adverse events.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Headache, Pain, Urticaria
Clinical narrative: Experienced dizziness and vertigo for 2-3 days. Broke out in hives day after vaccination which continued for 3 days.  Body aches, headache and fatigue.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vertigo
Clinical narrative: Experienced dizziness and vertigo for 2-3 days. Broke out in hives day after vaccination which continued for 3 days.  Body aches, headache and fatigue.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, B-cell lymphoma, Computerised tomogram, Fatigue, Laboratory test
Clinical narrative: I am not sure it is an adverse event but I was diagnosed with Metastatic B-cell lymphoma in 10/2021.  I had  been having hip pain for several months and also noticed enlarged lymph nodes in my neck in early September 2021.  I also had some joint pain and generalized fatigue in 2/2021
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Metastatic lymphoma, Positron emission tomogram
Clinical narrative: I am not sure it is an adverse event but I was diagnosed with Metastatic B-cell lymphoma in 10/2021.  I had  been having hip pain for several months and also noticed enlarged lymph nodes in my neck in early September 2021.  I also had some joint pain and generalized fatigue in 2/2021
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Ear pain, Hyperacusis, Tinnitus
Clinical narrative: Mild Tinnitus started after my first vaccine on 4/1/2021.  Tinnitus worsened after 2nd shot on 4/29/2021.  Tinnitus worsened after getting the booster on 12/17/2021.  One year later without getting any more boosters my Tinnitus has worsened with a new symptom of inner ear pain and heightened sensitivity to sound.  Pain is worse in my right ear but present in both.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Magnetic resonance imaging head, Mental impairment, Reading disorder, Scan with contrast
Clinical narrative: I suffered a mini stroke. [TIA} I had difficulty understanding written words and people speaking to me. it took me a few minutes to realize it was me and not them.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: I suffered a mini stroke. [TIA} I had difficulty understanding written words and people speaking to me. it took me a few minutes to realize it was me and not them.
Age: 68.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Unevaluable event, X-ray
Clinical narrative: Af hospital, pulse 145
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Ischaemic stroke, Scan with contrast
Clinical narrative: ischemic stroke/treatment lisonopril HCTZ 20/25mg, atorvastatin 20mg, aspirin 1 X day, metoprolol ER 25 mg 2 X day.  Permanent.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: INCORRECT DOSE ADMINISTERED; DOSE ADMINISTERED WITHOUT DILUTION
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Chills, Injection site pain, Pain, Pain in extremity
Clinical narrative: Injection given about 10 A.M.   Some slight soreness at injection site but no other symptoms until about 9 P.M.  Then radiating pain in injection arm for entire length of arm.  Moderate chest pain with heart palpitations.  Chills but slightly subnormal temperature (97.1).  Almost called 911 but delayed doing that.  Did not take  BP or anything for the pain.  All symptoms subsided almost instantaneously at approx. 2 A.M.  Jan. 12th.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Palpitations
Clinical narrative: Injection given about 10 A.M.   Some slight soreness at injection site but no other symptoms until about 9 P.M.  Then radiating pain in injection arm for entire length of arm.  Moderate chest pain with heart palpitations.  Chills but slightly subnormal temperature (97.1).  Almost called 911 but delayed doing that.  Did not take  BP or anything for the pain.  All symptoms subsided almost instantaneously at approx. 2 A.M.  Jan. 12th.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: N/A Left voicemail for patient
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Sore left arm after vaccination. My son was given the wrong dose of the covid bivalent vaccine. He was administered an adult dose instead of the pediatric dose.
Age: 75.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient stated it was his 3rd dose of the pfizer vaccine when it was actually his 6th dose. So far after talking to him he had no side affects.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site muscle weakness, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Expected soreness, swelling and muscle weakness for 48 hours resolved to ongoing soreness and muscle weakness in upper left arm. Occasional (2-4x daily) shooting pains down arm. Continues to be sore to touch muscle. Continues to be difficult to lift and carry with this arm.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Expected soreness, swelling and muscle weakness for 48 hours resolved to ongoing soreness and muscle weakness in upper left arm. Occasional (2-4x daily) shooting pains down arm. Continues to be sore to touch muscle. Continues to be difficult to lift and carry with this arm.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Feeling hot, Pallor, Supine position
Clinical narrative: lightheaded/dizzy, pale, clammy/hot feeling; 5 minutes after receiving vaccine. Histsory of feeling dizzy after vaccines/blood draws. RPh had patient remain for observation in private area first in supine position, then seated. under direct pharmacist observation 12:40pm-1:11pm. Patient declined EMS services.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Muscular weakness, Myalgia
Clinical narrative: 1 WEEK AFTER VACCINATION, PATIENT STARTED TO FEEL MUSCLE ACHNESS, MUSCLE WEAKNESS, AND DIZZINESS
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Agnosia, Anticoagulant therapy, Atrial fibrillation, Carotid artery thrombosis, Cerebral thrombosis
Clinical narrative: Patient experienced an ischemic stroke per spouse.  Stated this happened 3 days after receiving pfizer bivalent injection.  It was the 4th shot he has received, prior were all moderna covid 19 shots.  Patient had two surgeries for the brain clot.  One was to clear out the carotid artery brain clot, and then a second one that required an incision to clear the carotid out again for the patient.  He went into afib as well at some point in time, and is now on therapy for that, but can have one of two elective surgeries to come off of the blood thinner he is required to take for controlled afib currently.  Time course started at 9:30pm on 10/16/22 where the local fire department/rescue squad transported him to hospital, and then on 10/17/22 he was transferred to different hospital where he stayed from 10/17/22 to 10/27/22, then progressed to a rehab clinic where he stayed until 11/4/22.   He is learning to recognize things again currently, speak more fluently, but is continuing to have ongoing issues from it that could take 6 months to a year to finely tune more, but will never more than likely be 100% again.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ischaemic stroke, Laboratory test, Speech disorder, Surgery
Clinical narrative: Patient experienced an ischemic stroke per spouse.  Stated this happened 3 days after receiving pfizer bivalent injection.  It was the 4th shot he has received, prior were all moderna covid 19 shots.  Patient had two surgeries for the brain clot.  One was to clear out the carotid artery brain clot, and then a second one that required an incision to clear the carotid out again for the patient.  He went into afib as well at some point in time, and is now on therapy for that, but can have one of two elective surgeries to come off of the blood thinner he is required to take for controlled afib currently.  Time course started at 9:30pm on 10/16/22 where the local fire department/rescue squad transported him to hospital, and then on 10/17/22 he was transferred to different hospital where he stayed from 10/17/22 to 10/27/22, then progressed to a rehab clinic where he stayed until 11/4/22.   He is learning to recognize things again currently, speak more fluently, but is continuing to have ongoing issues from it that could take 6 months to a year to finely tune more, but will never more than likely be 100% again.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood loss anaemia, Haemoglobin decreased, Headache, Heavy menstrual bleeding
Clinical narrative: Started out with irregular menstrual spotting last a  couple of months. Increased  weakness  . Frequent headaches. After a yr ended up in the ER due to blood loss and required first ever blood transfusion due to increased bleeding with menstrual periods. Eventually lead to fibroids . Now recommended for  surgery due to blood consistent bleeding. Now a chronic condition. Dx with Anemia
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular, Transfusion, Uterine leiomyoma
Clinical narrative: Started out with irregular menstrual spotting last a  couple of months. Increased  weakness  . Frequent headaches. After a yr ended up in the ER due to blood loss and required first ever blood transfusion due to increased bleeding with menstrual periods. Eventually lead to fibroids . Now recommended for  surgery due to blood consistent bleeding. Now a chronic condition. Dx with Anemia
Age: 58.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Computerised tomogram head abnormal, Magnetic resonance imaging head abnormal, Scan with contrast abnormal, Sensory disturbance, Thalamic stroke
Clinical narrative: Roughly twenty days after vaccination, I had a thalamic stroke, diagnosed by CT scan and MRI at Hospital. No underlying risk factors.  Stroke caused sensory  damage but no apparent mental or mobility effects. Having read the Reuters summary of the concerns about Pfizer bivalent I thought I should report this.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac monitoring abnormal, Cardioversion, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: Starting in July I was very tired.  Called my PCP and set up appointment for August.  While there and checking my pulse she was concerned about it being irregular.  Did an EKG and discovered I was in AFIB.  Set up a monitor for my heart in early September which showed I was in AFIB 98% of the time.  Also did a sleep study for apnea which was negative.  Met with cardiologist in late October set up a Cardioversion for the 23 of November.  The cardio version returned my heart rate to a normal rythm.  The AFIB returned in early December.  Another cardio version is scheduled for 16 January.  I have continued fatigue and shortness of breath.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular, Sleep study normal
Clinical narrative: Starting in July I was very tired.  Called my PCP and set up appointment for August.  While there and checking my pulse she was concerned about it being irregular.  Did an EKG and discovered I was in AFIB.  Set up a monitor for my heart in early September which showed I was in AFIB 98% of the time.  Also did a sleep study for apnea which was negative.  Met with cardiologist in late October set up a Cardioversion for the 23 of November.  The cardio version returned my heart rate to a normal rythm.  The AFIB returned in early December.  Another cardio version is scheduled for 16 January.  I have continued fatigue and shortness of breath.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac monitoring, Cardiac stress test, Cerebrovascular accident, Computerised tomogram, Echocardiogram
Clinical narrative: Hospitalized on Oct 3rd with symptoms of stroke.  Stroke confirmed by hospital staff on Oct 4th and neurologist on reading films.  Mild stroke.  No prior cardiac or brain issues.  Normal blood pressure.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Magnetic resonance imaging, Neurological symptom
Clinical narrative: Hospitalized on Oct 3rd with symptoms of stroke.  Stroke confirmed by hospital staff on Oct 4th and neurologist on reading films.  Mild stroke.  No prior cardiac or brain issues.  Normal blood pressure.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphonia, Emotional distress, Haemoptysis, Laryngitis, Oropharyngeal pain
Clinical narrative: Developed a severe sore throat about 24 hours after the vaccine.  The following day coughed up blood from the throat. On January 11 developed severe laryngitis.  The condition continues without relief.  Sore throat  and no voice .
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: The 1st shot I had nothing, no side affects, nothing.  Got 2nd shot month later, after about 10 hours, my toes on both feet went completely numb.  I figured it was a side effect and it would go away.  Have been putting up with it for a long time, Now my big toe and 2nd toes on both feet are numb.  I have tingling here and there and nothing I haven't been able to live with but it's not going away.  I haven't done the boosters due to the fact that these side effects have not gone away.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: Patient came to clinic to receive Moderna Bivalent COVID vaccine on 12/28/22. However, the MDV was  left overnight without any documentation when it was drawn (vial is only good 12 hours after puncture). Patient has been notified and will return in 2 months for another bivalent dose. This event is reported as an administration error, no adverse event.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Rash, Rash vesicular, Scab
Clinical narrative: starting day 3 terrible pins and needles hot tinly blistery rash covering neck down to torso.  end of day 7, still think itchy skin in affected areas and rash starting to scab over in spots.  still itchy.  taking benadryl and zyrtec, also using brnadryl creme.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: starting day 3 terrible pins and needles hot tinly blistery rash covering neck down to torso.  end of day 7, still think itchy skin in affected areas and rash starting to scab over in spots.  still itchy.  taking benadryl and zyrtec, also using brnadryl creme.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia
Clinical narrative: Ataxia. Lasted weeks
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Product administration error
Clinical narrative: Patient already received Pfizer COVID vaccine primary series on 4/21/21 and 5/12/21. On 12/28/22, patient was supposed to receive Moderna bivalent COVID vaccine booster, but was inadvertently given the Moderna monovalent COVID vaccine. This is reported as an administration error, no adverse event occurred. Patient is coming back in 2 months to receive the bivalent COVID vaccine booster.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia
Clinical narrative: Lost of sense of taste for just less than a day (18-20 hours), but was noticeable.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Headache, Loss of consciousness, Swelling, Syncope
Clinical narrative: I have had 3 bouts of unconsciousness since receiving the vaccine yesterday.  They just happen with about a 3 second warning, something feels off in my head then I collapsed and was out for a short time.  The front of my head has been painful since, it feels like swellings.  I am not prone to migraines or headaches.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal insufficiency, Adrenocortical insufficiency acute, Blood corticotrophin abnormal, Fatigue, Laboratory test
Clinical narrative: Fever, fatigue, nausea, sore muscles, that same evening and then adrenal failure a few months later
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, fatigue, nausea, sore muscles, that same evening and then adrenal failure a few months later
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Severe fatigue starting 6 pm and lasting 48 hours Headache moderate, took 400 mg ibuprofen lasted 36 hrs, started 6 pm Chills started 6 pm, lasted 36 hours
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acne, Arthralgia, Cough, Erythema, Fatigue
Clinical narrative: Sept 25 4 hrs after vaccine feeling tired-then at 8:30 pm driving home from dinner my right hip had much pain and then my right leg would not move and pain traveled down leg to toes, about 6 minutes later the left one did the same from hip to toes--I had to pull off the road and massage both limbs for about 10 minutes  had a hard drive rest of the way home  my drive should have taken 10-12 minutes it took me 25 minutes.  On September 27, 2022 at about 3am I developed a horrendous cough, still have the cough today and will see Pulmonologist on January 17, 2023 to find out why this cough iss lingering--it is not Asthma nor am I wheezing. October 5, I developed a rash on my face, face bright red, and then Oco I then developed white heads where all the red blotches and rash was  Saw Dr., Dermatologist on Dec 5 and dx with Rosacea Scripted Doxycycline orally and Metronidazole topically. Saw Dr. for f/u on 05JAN23 and face had cleared  d/c Oral med and continue for another week or two with Topical.  Cough Still remained so not an infection.  Adverse reaction on April 13, 2022 woke up middle of night not feeling well sat up in bed and became lightheaded thought my electrolytes were low got out to walk to kitchen took me 30 minutes and drank Powerade zero and stayed in the family room adjacent to the kitchen.  all resolved by 10 am on April 14,2022
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Impaired driving ability, Musculoskeletal disorder, Pain in extremity, Rash, Rash macular
Clinical narrative: Sept 25 4 hrs after vaccine feeling tired-then at 8:30 pm driving home from dinner my right hip had much pain and then my right leg would not move and pain traveled down leg to toes, about 6 minutes later the left one did the same from hip to toes--I had to pull off the road and massage both limbs for about 10 minutes  had a hard drive rest of the way home  my drive should have taken 10-12 minutes it took me 25 minutes.  On September 27, 2022 at about 3am I developed a horrendous cough, still have the cough today and will see Pulmonologist on January 17, 2023 to find out why this cough iss lingering--it is not Asthma nor am I wheezing. October 5, I developed a rash on my face, face bright red, and then Oco I then developed white heads where all the red blotches and rash was  Saw Dr., Dermatologist on Dec 5 and dx with Rosacea Scripted Doxycycline orally and Metronidazole topically. Saw Dr. for f/u on 05JAN23 and face had cleared  d/c Oral med and continue for another week or two with Topical.  Cough Still remained so not an infection.  Adverse reaction on April 13, 2022 woke up middle of night not feeling well sat up in bed and became lightheaded thought my electrolytes were low got out to walk to kitchen took me 30 minutes and drank Powerade zero and stayed in the family room adjacent to the kitchen.  all resolved by 10 am on April 14,2022
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rosacea, Ultrasound Doppler
Clinical narrative: Sept 25 4 hrs after vaccine feeling tired-then at 8:30 pm driving home from dinner my right hip had much pain and then my right leg would not move and pain traveled down leg to toes, about 6 minutes later the left one did the same from hip to toes--I had to pull off the road and massage both limbs for about 10 minutes  had a hard drive rest of the way home  my drive should have taken 10-12 minutes it took me 25 minutes.  On September 27, 2022 at about 3am I developed a horrendous cough, still have the cough today and will see Pulmonologist on January 17, 2023 to find out why this cough iss lingering--it is not Asthma nor am I wheezing. October 5, I developed a rash on my face, face bright red, and then Oco I then developed white heads where all the red blotches and rash was  Saw Dr., Dermatologist on Dec 5 and dx with Rosacea Scripted Doxycycline orally and Metronidazole topically. Saw Dr. for f/u on 05JAN23 and face had cleared  d/c Oral med and continue for another week or two with Topical.  Cough Still remained so not an infection.  Adverse reaction on April 13, 2022 woke up middle of night not feeling well sat up in bed and became lightheaded thought my electrolytes were low got out to walk to kitchen took me 30 minutes and drank Powerade zero and stayed in the family room adjacent to the kitchen.  all resolved by 10 am on April 14,2022
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 8 patients received doses after the 30-day Use By Date; No Adverse Event; 8 patients received doses after the 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date) and PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date).    Concomitant products were not provided. It was unknown whether the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vials were 2.5 ml size taken from open carton. The vial was initially stored in the refrigerator on 05Dec2022  The Vials did not undergo any temperature excursion. This case contains information for the 4th of 8 patients described by the report. The HCP did not want to provide any more information. Treatment medication were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696087 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696087:Patient 5 out of 8 Patients
Age: 61.0
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the Moderna bivalent vaccine instead of the monovalent as the first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent vaccine instead of the monovalent as the first dose.) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent vaccine instead of the monovalent as the first dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent vaccine instead of the monovalent as the first dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent vaccine instead of the monovalent as the first dose.).    No concomitant medications were reported. It was reported that there was a vaccine administration error. patient received the Moderna bivalent vaccine instead of the Monovalent as the first dose.  Further it was stated that they administered the monovalent about 6 weeks after the bivalent was given. No treatment medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Brain death, Brain stem haemorrhage, Injury, Mechanical ventilation
Clinical narrative: Level I Trauma after being found down in his hotel room, found to have large brainstem hemorrhage and acute respiratory failure requiring mechanical ventilation. Brain death testing completed 1/12, TOD confirmed at 1621.  Patient later LOOP'd (organ donation) on 1/14/2023
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Organ donor
Clinical narrative: Level I Trauma after being found down in his hotel room, found to have large brainstem hemorrhage and acute respiratory failure requiring mechanical ventilation. Brain death testing completed 1/12, TOD confirmed at 1621.  Patient later LOOP'd (organ donation) on 1/14/2023
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 at 08:00 as dose 1, single (Lot number: EL9231) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  Additional information: The patient did not have any prior vaccinations within 4 weeks of BNT162b2. It was reported in the initial report that the patient experienced hair loss this after getting the first COVID-19 vaccine.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional AEs; CMA calling to report concomitant administration of PROQUAD and VARIVAX to 1 year old patient on 12/22/2022. Caller states that patient received each vaccine in different thigh. No further information provided, no additional AEs, no PQCs reported.; This spontaneous report was received from a medical assistant referring to a 1-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 22-DEC-2022, the patient was vaccinated with concomitant administration of varicella virus vaccine live (oka/merck)(VARIVAX) (0.5ml/once, lot # U015687, expiration date 18-MAY-2023; route was not reported)) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live ((recombinant Human albumin) rHA) (PROQUAD) (0.5ml/once, lot # W024547, expiration date 31-JAN-2024, route was not reported) for prophylaxis (overdose). The patient received each vaccine in different thigh. No additional adverse event was reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Electrocardiogram abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: Caller said the patient fainted and became unresponsive about 5 to 10 minutes after receiving the dose. EKG was then performed in the office which showed some abnormalities so patient was sent; became unresponsive about 5 to 10 minutes; EKG was abnormal; This spontaneous report has been received from a nurse referring to a 4-year-old male patient.  The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 10-JAN-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliters, lot number W010524 has been verified to be a valid lot number with expiration date on 25-SEP-2023  (vaccination scheme, frequency, route of administration and anatomical site of injection were not provided) administered as routine vaccination. On the same date, about 5 to 10 minutes after receiving the dose the patient fainted and became unresponsive (syncope) (unresponsive to stimuli), an electrocardiogram (EKG) was then performed in the office which showed some abnormalities (electrocardiogram abnormal), following the patient was sent to emergency room. No further information was provided.  The outcome and causality assessment of the events was not provided.  Upon internal review the events syncope and unresponsive to stimuli were determined to be medically significant.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient administered the Moderna monovalent vaccine instead of the bivalent booster dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient administered the Moderna monovalent vaccine instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient administered the Moderna monovalent vaccine instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient administered the Moderna monovalent vaccine instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient administered the Moderna monovalent vaccine instead of the bivalent booster dose).    No concomitant medications were provided by the reporter.  HCP reported that their facility only administers the Pfizer vaccine. However, they had a pediatric patient who chose to get the Moderna COVID-19 vaccine.   The patient received 2 doses of the Moderna COVID-19 vaccine for their primary series and went to urgent care recently to get a booster dose. The urgent care inadvertently administered the Moderna monovalent vaccine to this patient instead of the bivalent booster dose. They told the patient's parents that CDC has advised that the patient can receive the Moderna bivalent but 8 weeks after receiving the most recent dose. HCP did not have any patient information at this time or any details regarding the event.  No treatment medications were provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose).    No concomitant medication information provided.  It was reported that the patient had received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose. Bivalent Lot 057A22A expiration date 06-Feb-2023.  No treatment information provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received monovalent Moderna Covid-19 vaccine instead of Moderna bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine instead of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     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 06-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine instead of Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine instead of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine instead of Moderna bivalent vaccine).    No concomitant medications were reported.  The patient received monovalent Moderna Covid-19 vaccine instead of Moderna bivalent vaccine. Lot 057A22A expiration date February 6, 2023,  No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023; No Adverse Event; 8 patients received doses after the 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date) and PRODUCT STORAGE ERROR (On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023).    Concomitant medications were not reported.  This case contains information for the patient 8 out of 8 adult patients. The vial size was 2.5 ml. The vial did not undergo any temperature excursions. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696087 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696087:Patient 8out of 8 Patients
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Blood test, Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (Could barely walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not even hold a coffee cup) and ARTHRALGIA (joint pain/inflammation) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2022, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 11 milligram. In 2021, the patient experienced GAIT DISTURBANCE (Could barely walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not even hold a coffee cup) and ARTHRALGIA (joint pain/inflammation). The patient was treated with VITAMIN D NOS at a dose of 1500, wk; IBUPROFEN (ADVIL [IBUPROFEN]) in 2021 at an unspecified dose and frequency; METHOTREXATE at a dose of 2.5 milligram once a week; FOLIC ACID at a dose of for 4-6 weeks; PREDNISONE at a dose of 40 milligram every two weeks; PREDNISONE at a dose of 30 milligram every two weeks; PREDNISONE at a dose of 20 milligram every two weeks; PREDNISONE at a dose of 50 milligram every two weeks and PREDNISONE at a dose of 10 milligram every two weeks. At the time of the report, GAIT DISTURBANCE (Could barely walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not even hold a coffee cup) and ARTHRALGIA (joint pain/inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal.         No concomitant medications were reported.