chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Insomnia, Laboratory test, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: Received booster in January of 2022. Within a week of booster shot, started having severe migraines that got to a point of affecting eyesight in right eye. Reported headaches daily to company nurse. Nurse gave Tylenol on site, and recommended ice for the discomfort. Nurse then instructed to return to work as normal. On 2/4/2022, while at home getting ready for work, had a seizure and was unconscious for an extended amount of time. Was able to awaken, and dial 911 for an ambulance. Was taken to the Hospital, CAT scans and other tests were run including blood tests. Later was diagnosed as experiencing a grand mal seizure at home, which led to the hospital stay. CAT scans later revealed a large hematoma on right side of brain, and several blood clots on the brain. Was hospitalized for 3.5 weeks. During this time, experienced another grand mal seizure that resulted in coding and having to be revived. After stabilizing from seizure, underwent surgery to drill 3 holes on the right side of skull to drain blood from hematoma. Underwent a surgery through artery in right arm to cauterize hematoma to stop the active bleeding on the brain after being drained. Have had to report to radiology and neurology several times between now and then for follow up appointments regarding medications, pain levels, and monitoring brain bleeding and levels. Since hospital stay, have had to undergo another cauterizing surgery through right groin for more active bleeding on the brain from hematoma. Currently have a large thrombosis on brain that cannot be drained, operated on, or treated in any way (including blood thinners) until all other bleeding has been stopped and brought under control. Cannot drive, cannot work, short term disability from February until May 5th, 2022. Presently still not cleared to work or drive, have to rely on friends and family for rides to doctor appointments and food shopping trips, etc. Presently on Gabapentin 800mg 3x daily for pain and post traumatic insomnia treatment,  and Keppa 1000mg 2x daily. No history of migraines, seizures, or blood clots in previous medical history or records.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pain, Resuscitation, Visual impairment
Clinical narrative: Received booster in January of 2022. Within a week of booster shot, started having severe migraines that got to a point of affecting eyesight in right eye. Reported headaches daily to company nurse. Nurse gave Tylenol on site, and recommended ice for the discomfort. Nurse then instructed to return to work as normal. On 2/4/2022, while at home getting ready for work, had a seizure and was unconscious for an extended amount of time. Was able to awaken, and dial 911 for an ambulance. Was taken to the Hospital, CAT scans and other tests were run including blood tests. Later was diagnosed as experiencing a grand mal seizure at home, which led to the hospital stay. CAT scans later revealed a large hematoma on right side of brain, and several blood clots on the brain. Was hospitalized for 3.5 weeks. During this time, experienced another grand mal seizure that resulted in coding and having to be revived. After stabilizing from seizure, underwent surgery to drill 3 holes on the right side of skull to drain blood from hematoma. Underwent a surgery through artery in right arm to cauterize hematoma to stop the active bleeding on the brain after being drained. Have had to report to radiology and neurology several times between now and then for follow up appointments regarding medications, pain levels, and monitoring brain bleeding and levels. Since hospital stay, have had to undergo another cauterizing surgery through right groin for more active bleeding on the brain from hematoma. Currently have a large thrombosis on brain that cannot be drained, operated on, or treated in any way (including blood thinners) until all other bleeding has been stopped and brought under control. Cannot drive, cannot work, short term disability from February until May 5th, 2022. Presently still not cleared to work or drive, have to rely on friends and family for rides to doctor appointments and food shopping trips, etc. Presently on Gabapentin 800mg 3x daily for pain and post traumatic insomnia treatment,  and Keppa 1000mg 2x daily. No history of migraines, seizures, or blood clots in previous medical history or records.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Cold sweat, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Patient report being dizzy . The facility nurse took blood pressure and heart rate while I supported patient in her chair. She was sweating and clammy to the touch. I applied an ice pack on her neck and head . She yawned about 8 times in 90 seconds. Her blood pressure was very low.  Since she was diabetic we checked her blood sugar and it was 190.  She said several times she thought she was feeling better so we transferred her to the wellness center for more observation.  The patient reported her tongue was swelling so I decided to administer epinephrine into her left thigh.  The  nurse called EMS to take over care at this point. The patient reported an improvement within minutes.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Yawning
Clinical narrative: Patient report being dizzy . The facility nurse took blood pressure and heart rate while I supported patient in her chair. She was sweating and clammy to the touch. I applied an ice pack on her neck and head . She yawned about 8 times in 90 seconds. Her blood pressure was very low.  Since she was diabetic we checked her blood sugar and it was 190.  She said several times she thought she was feeling better so we transferred her to the wellness center for more observation.  The patient reported her tongue was swelling so I decided to administer epinephrine into her left thigh.  The  nurse called EMS to take over care at this point. The patient reported an improvement within minutes.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Echocardiogram, Hypoaesthesia
Clinical narrative: feet numbness chest/arms/ belly bloat
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles started last year and I have had repeated outbreaks since. I got my first attack less than 30 days after second shot and get a new one about every 60 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Dizziness
Clinical narrative: Chills started 1/2 hr post vaccine, but no other symptoms initially. By 11pm 5/2/22 I had extreme body aches; joint pain; intense chills / sweats; nausea; headache. The body aches have reduced somewhat 5/4/22 with Tylenol and 8-9 pints of water in 12hour cycles; however my stomach is still upset; intense chills/ sweats continue; joints still painful. As of 5/4/22 I am frequently dizzy and having 'brain-fog.' I did not initially have dizziness. I have had to cancel all commitments and cannot drive safely. While none of these things are life-threatening they continue to be extremely unpleasant and debilitating.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Impaired driving ability, Loss of personal independence in daily activities
Clinical narrative: Chills started 1/2 hr post vaccine, but no other symptoms initially. By 11pm 5/2/22 I had extreme body aches; joint pain; intense chills / sweats; nausea; headache. The body aches have reduced somewhat 5/4/22 with Tylenol and 8-9 pints of water in 12hour cycles; however my stomach is still upset; intense chills/ sweats continue; joints still painful. As of 5/4/22 I am frequently dizzy and having 'brain-fog.' I did not initially have dizziness. I have had to cancel all commitments and cannot drive safely. While none of these things are life-threatening they continue to be extremely unpleasant and debilitating.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Chills started 1/2 hr post vaccine, but no other symptoms initially. By 11pm 5/2/22 I had extreme body aches; joint pain; intense chills / sweats; nausea; headache. The body aches have reduced somewhat 5/4/22 with Tylenol and 8-9 pints of water in 12hour cycles; however my stomach is still upset; intense chills/ sweats continue; joints still painful. As of 5/4/22 I am frequently dizzy and having 'brain-fog.' I did not initially have dizziness. I have had to cancel all commitments and cannot drive safely. While none of these things are life-threatening they continue to be extremely unpleasant and debilitating.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, Blood sodium decreased, C-reactive protein increased, Confusional state, Cortisol increased
Clinical narrative: Initially had body aches, fatigue.  But then slept up to 20 hours/day, got confused by about day 3.  Lost appetite, things tasted bad.  Slept so much wasn't drinking fluids.  Ultimately so confused labs were done - showed significant hyponatremia (Sodium 123).  No signs SIADH. Admitted to Hospital 4/26-4/28. Improved with hydration with NS.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine negative, Decreased appetite, Fatigue, Fluid intake reduced, Haptoglobin increased
Clinical narrative: Initially had body aches, fatigue.  But then slept up to 20 hours/day, got confused by about day 3.  Lost appetite, things tasted bad.  Slept so much wasn't drinking fluids.  Ultimately so confused labs were done - showed significant hyponatremia (Sodium 123).  No signs SIADH. Admitted to Hospital 4/26-4/28. Improved with hydration with NS.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Hyponatraemia, Inflammatory marker increased, Pain, Red blood cell sedimentation rate increased
Clinical narrative: Initially had body aches, fatigue.  But then slept up to 20 hours/day, got confused by about day 3.  Lost appetite, things tasted bad.  Slept so much wasn't drinking fluids.  Ultimately so confused labs were done - showed significant hyponatremia (Sodium 123).  No signs SIADH. Admitted to Hospital 4/26-4/28. Improved with hydration with NS.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, White blood cell count increased
Clinical narrative: Initially had body aches, fatigue.  But then slept up to 20 hours/day, got confused by about day 3.  Lost appetite, things tasted bad.  Slept so much wasn't drinking fluids.  Ultimately so confused labs were done - showed significant hyponatremia (Sodium 123).  No signs SIADH. Admitted to Hospital 4/26-4/28. Improved with hydration with NS.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neuralgia
Clinical narrative: following a call from Immunization System that informed us that this pt had a Moderna vaccine 3 days prior to his Janssen vaccine I called the patient on 05/04/2022 to verify he had both vaccines, get details and information about adverse reactions.  He stated that he has had nerve pain since the 2nd vaccine was administered from his shoulder to his elbow.  He stated that he has not sought treatment for this at this time.  I advised him to see a doctor regarding this.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Disorientation, Ear pain, Facial pain, Fatigue
Clinical narrative: Patient complained of fatigue, body aches, and other flu-like symptoms starting about 12 hours after vaccination.  The following day (5/1), the patient states she passed out for 12 hours, had pain that was severe and radiated throughout the head, ear, and face.  Full body muscle aches so severe in the back, the patient worried it may have been her kidneys.  Also experienced a fever.  The patient thought about going to the hospital, but did not.  Starting 5/2, patient was experiencing some disorientation and issues with hand coordination. Fatigue and muscle aches continue, but less severe, same with the pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Loss of consciousness, Myalgia, Pain
Clinical narrative: Patient complained of fatigue, body aches, and other flu-like symptoms starting about 12 hours after vaccination.  The following day (5/1), the patient states she passed out for 12 hours, had pain that was severe and radiated throughout the head, ear, and face.  Full body muscle aches so severe in the back, the patient worried it may have been her kidneys.  Also experienced a fever.  The patient thought about going to the hospital, but did not.  Starting 5/2, patient was experiencing some disorientation and issues with hand coordination. Fatigue and muscle aches continue, but less severe, same with the pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient complained of fatigue, body aches, and other flu-like symptoms starting about 12 hours after vaccination.  The following day (5/1), the patient states she passed out for 12 hours, had pain that was severe and radiated throughout the head, ear, and face.  Full body muscle aches so severe in the back, the patient worried it may have been her kidneys.  Also experienced a fever.  The patient thought about going to the hospital, but did not.  Starting 5/2, patient was experiencing some disorientation and issues with hand coordination. Fatigue and muscle aches continue, but less severe, same with the pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Fatigue, Respiratory tract congestion
Clinical narrative: 3 other members of my family had COVID-19 beginning Dec 18, 2021. I was tired and run-down but did not test positive while they were sick. I had my booster vaccination on Jan 5, 2022. I then tested positive for COVID-19 on January 27, 2022. I was very fatigued, congested, and had a cough. No high fever. My symptoms were not as serious as my family members. My son's turned into COVID-19 pneumonia. My husband was down for about 2 weeks with a horrible cough, fever and fatigue. My daughter ran fever and had a lingering cough.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 3 other members of my family had COVID-19 beginning Dec 18, 2021. I was tired and run-down but did not test positive while they were sick. I had my booster vaccination on Jan 5, 2022. I then tested positive for COVID-19 on January 27, 2022. I was very fatigued, congested, and had a cough. No high fever. My symptoms were not as serious as my family members. My son's turned into COVID-19 pneumonia. My husband was down for about 2 weeks with a horrible cough, fever and fatigue. My daughter ran fever and had a lingering cough.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio increased
Clinical narrative: Patient claims her INR usually runs 2.5 and 2 days after her Moderna booster shot her INR was 4.3. She could not think of anything else besides her booster shot that was different that could have caused this.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: Booster (#2 in series) received 04/23/2022.  Approx. 0430 hours 4/25/2022, awakened in severe pain over entire body and in joints.  Severe pain has persisted and not lessened to any degree in the interim (to date; 5/04/2022).  Pain rating is averaging 5-6 on the 0-10 scale and fatigue has set in.  Developed mild (100.0 degrees F.) temperature on 5/2/2022, which has since subsided.  Have been taking Naproxen Sodium twice daily, assistance with this is minimal.  Have sought treatment at Urgent Care for pain/fatigue, however Urgent Care doctor's recommendation(s) included to continue with Naproxen Sodium and report back to Urgent Care if pain/fatigue worsens or fails to subside.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient given improper vaccine since less than 18 years of age.  No adverse effect reports thusfar.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy
Clinical narrative: Lymph node swelling, difficulty swallowing for 1 week
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient had syringe inserted into his right deltoid, no vaccine was introduced into arm and patient was not vaccinated. Syringe was removed from arm and disposed of in sharps container, bandaid was placed on patient?s arm, he and mother were informed of what occured. Syringe had been prepared at event 3 hours earlier and was accidentally frozen during travel. Two other syringes that were also affected were immediately disposed of. Mother was informed and gave her option of waiting while new syringes were drawn up. She declined and decided to not have her son vaccinated today.   Patient had no symptoms or adverse event reported from Mother after vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Accidentally gave a 5th dose of moderna vaccine to patient and another dose of flu vaccine.   I forgot to run a Immunization report before evaluating patient's immunization history.   Afterwards, when I was entering the info in the Immunization database, I saw patient already got flu vaccine (8/14/21  and Moderna (2 doses at Health Clinic (3/1/21, 3/29/21) AND pharmacy (11/03/21, 1/24/02)).  I notified the pharmacists at pharmacy and store, and spoke to the health office.   Patient denied every getting any aforementioned shots above.   She told myself and tech that this was her first shot at the drop-off station.    After a 15 minute observation period, patient didn't report any adverse outcomes.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Discomfort, Headache, Hypoacusis, Inflammation
Clinical narrative: Severe Virtigo and loss of partial loss of hearing and vision. headaches and overall discomfort. Sluggish, unsteady
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Labyrinthitis, Sluggishness, VIIIth nerve injury, Vertigo, Visual impairment
Clinical narrative: Severe Virtigo and loss of partial loss of hearing and vision. headaches and overall discomfort. Sluggish, unsteady
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test normal, Computerised tomogram head normal, Computerised tomogram spine, Electrocardiogram normal
Clinical narrative: Weakness with numbness to both hands and legs. Severe headache the next morning after the vaccine. 1st visit 2/10/2022, bloodwork; EKG; CT head done. Given solumedrol, Zofran, Pepcid, and Demerol for the severe headache. Next day, continued severe headache with progressive numbness to left arm hand, leg, and foot. 2/12/2022 2nd visit. Symptoms: Complete immobility of the left arm and left leg. Numbness to the left-side of the face. Continued severe headache. Blurred vision. Bloodwork, EKG, CT head and spine obtained. Lumbar puncture attempted. No significant finding. Informed to follow-up with PCP Monday. By Monday continued immobility with numbness to left-side of the body.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Lumbar puncture normal, Magnetic resonance imaging head normal, Movement disorder
Clinical narrative: Weakness with numbness to both hands and legs. Severe headache the next morning after the vaccine. 1st visit 2/10/2022, bloodwork; EKG; CT head done. Given solumedrol, Zofran, Pepcid, and Demerol for the severe headache. Next day, continued severe headache with progressive numbness to left arm hand, leg, and foot. 2/12/2022 2nd visit. Symptoms: Complete immobility of the left arm and left leg. Numbness to the left-side of the face. Continued severe headache. Blurred vision. Bloodwork, EKG, CT head and spine obtained. Lumbar puncture attempted. No significant finding. Informed to follow-up with PCP Monday. By Monday continued immobility with numbness to left-side of the body.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Weakness with numbness to both hands and legs. Severe headache the next morning after the vaccine. 1st visit 2/10/2022, bloodwork; EKG; CT head done. Given solumedrol, Zofran, Pepcid, and Demerol for the severe headache. Next day, continued severe headache with progressive numbness to left arm hand, leg, and foot. 2/12/2022 2nd visit. Symptoms: Complete immobility of the left arm and left leg. Numbness to the left-side of the face. Continued severe headache. Blurred vision. Bloodwork, EKG, CT head and spine obtained. Lumbar puncture attempted. No significant finding. Informed to follow-up with PCP Monday. By Monday continued immobility with numbness to left-side of the body.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Complication of pregnancy, Delivery, Echocardiogram abnormal, Exposure during pregnancy, Foetal cardiac disorder
Clinical narrative: First pregnancy with fetal abnormalities and complications; no hx of risk factors; genetic screenings normal; estimated date of delivery 15 July 2022; fetal demise detected at 28 weeks 5 days gestation; delivered 27 Apr 2022 at 1 lb 10 oz
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Foetal death, Foetal disorder, Prenatal screening test, Ultrasound antenatal screen abnormal
Clinical narrative: First pregnancy with fetal abnormalities and complications; no hx of risk factors; genetic screenings normal; estimated date of delivery 15 July 2022; fetal demise detected at 28 weeks 5 days gestation; delivered 27 Apr 2022 at 1 lb 10 oz
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Aches, fever, headache, exhaustion
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: Nerve pain radiating from injection site through nerves in arm, elbow,  wrist, hand and fingers
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Respiratory tract congestion, Seasonal allergy, Throat irritation, Tongue discolouration
Clinical narrative: Post nasal drip 4 weeks on going, started 6 months after vaccination. Discolored tongue; itchy throat. Very infrequent coughing and some times congestion.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: Post nasal drip 4 weeks on going, started 6 months after vaccination. Discolored tongue; itchy throat. Very infrequent coughing and some times congestion.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: 4/14 MMRV given 4:20pm 4/16 Temp 102 and febrile seizure AM EMS called See at Hospital
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient did not have a vaccine card a 3rd dose of vaccine was administered medical assistant gave this vaccine as a second dose.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He A given too early
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Dyspnoea, Pulmonary function test, Wheezing
Clinical narrative: CHRONIC PERSISTENT COUGH; DRY NON-PRODUCTIVE LASTING 24 HOURS DAY AND NIGHT WHEEZING AND SHORTNESS OF BREATH
Age: 1.08
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Culture urine, Dysuria, Full blood count, Hypophagia
Clinical narrative: 13 Month old son was prescribed Prevnar 13 vaccine but was given Pneumovax 23. We were not notified until the next day when we called to report son having fever 104 after Tylenol and IBU. He had not voided in over 12 hours and would not eat or drink. The nurse took down our information to speak with PCP. The nurse called back 2 hours later to tell us our son had been given wrong vaccine and to take him to ER.
Age: 1.08
Sex: M
Vaccine: PPV
Symptoms: Metabolic function test, Product administered to patient of inappropriate age, Pyrexia, Urine analysis, Wrong product administered
Clinical narrative: 13 Month old son was prescribed Prevnar 13 vaccine but was given Pneumovax 23. We were not notified until the next day when we called to report son having fever 104 after Tylenol and IBU. He had not voided in over 12 hours and would not eat or drink. The nurse took down our information to speak with PCP. The nurse called back 2 hours later to tell us our son had been given wrong vaccine and to take him to ER.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had my first shingles shot (Shingrix 50MCG/0.5ML INJ GLAX) at pharmacy on March 17, 2022. On March 26 I came down with Shingles. Was this coincidence or a reaction to the injection?
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Hyperhidrosis, Immediate post-injection reaction, Visual impairment
Clinical narrative: About 30 seconds after receiving the vaccine my vision started fading to black. I went completely black for 30 seconds. I was still conscious and was able to talk. I did not pass out. I was also sweating and felt a rush to my head. Paramedics were called and I was advised to stay calm and drink water. Shortly after they showed up they checked my blood pressure and my vision slowly came back. I stayed and rested there at the workplace clinic for another 10 minutes just to make sure I was okay. I did not go to a doctor or hospital.
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Dysstasia, Fatigue, Palpitations
Clinical narrative: This is a 36 year old previously healthy woman. She had COVID Vaccine (Pfizer, first dose) on April 2021 and immediately after the vaccination, she started experiencing dizziness and ringing sound in her ears. She went back home and these symptoms continued to get worse.  Ten days after vaccination, she felt very tired, dizzy and heart racing then she fell down but didn't pass out and was transferred to ER. At the ER she had a lot of work up done and was normal and was given some IV fluids then sent home. After going home she continued to have worsening symptoms and went to the ER again and repeated work up was negative and was sent home. She continued to feel worse and from April to June 2021 she was staying at bed and not able to walk or move. On August, she started to improve gradually  and be able to get out of bed and do some upright activities. On November she contracted a viral infection form her kids but didn't get tested for COVID as her symptoms looked like regular flu and she had a relapse with worsening symptoms and being bedridden. By beginning of December 2021 she started to experience some improvement in her symptoms and went to see a physical therapist who instructed her to do squatting exercises and once she started doing it, her symptom got worse again and spent the whole month of January 2022 in bed again. She continued to have gradual improvement and was able to get out of bed by February and by March 2022 she contracted another viral infection from her kids but she tested negative for COVID and she didn't experience worsening of her symptoms after that infection.  On March 25th she had a tilt table testing at hospital. The testing showed inappropriate sinus tachycardia
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bedridden, Dizziness, Echocardiogram normal, Fall, Fatigue
Clinical narrative: This is a 36 year old previously healthy woman. She had COVID Vaccine (Pfizer, first dose) on April 2021 and immediately after the vaccination, she started experiencing dizziness and ringing sound in her ears. She went back home and these symptoms continued to get worse.  Ten days after vaccination, she felt very tired, dizzy and heart racing then she fell down but didn't pass out and was transferred to ER. At the ER she had a lot of work up done and was normal and was given some IV fluids then sent home. After going home she continued to have worsening symptoms and went to the ER again and repeated work up was negative and was sent home. She continued to feel worse and from April to June 2021 she was staying at bed and not able to walk or move. On August, she started to improve gradually  and be able to get out of bed and do some upright activities. On November she contracted a viral infection form her kids but didn't get tested for COVID as her symptoms looked like regular flu and she had a relapse with worsening symptoms and being bedridden. By beginning of December 2021 she started to experience some improvement in her symptoms and went to see a physical therapist who instructed her to do squatting exercises and once she started doing it, her symptom got worse again and spent the whole month of January 2022 in bed again. She continued to have gradual improvement and was able to get out of bed by February and by March 2022 she contracted another viral infection from her kids but she tested negative for COVID and she didn't experience worsening of her symptoms after that infection.  On March 25th she had a tilt table testing at hospital. The testing showed inappropriate sinus tachycardia
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Gait inability, Immediate post-injection reaction, Influenza like illness, Laboratory test normal
Clinical narrative: This is a 36 year old previously healthy woman. She had COVID Vaccine (Pfizer, first dose) on April 2021 and immediately after the vaccination, she started experiencing dizziness and ringing sound in her ears. She went back home and these symptoms continued to get worse.  Ten days after vaccination, she felt very tired, dizzy and heart racing then she fell down but didn't pass out and was transferred to ER. At the ER she had a lot of work up done and was normal and was given some IV fluids then sent home. After going home she continued to have worsening symptoms and went to the ER again and repeated work up was negative and was sent home. She continued to feel worse and from April to June 2021 she was staying at bed and not able to walk or move. On August, she started to improve gradually  and be able to get out of bed and do some upright activities. On November she contracted a viral infection form her kids but didn't get tested for COVID as her symptoms looked like regular flu and she had a relapse with worsening symptoms and being bedridden. By beginning of December 2021 she started to experience some improvement in her symptoms and went to see a physical therapist who instructed her to do squatting exercises and once she started doing it, her symptom got worse again and spent the whole month of January 2022 in bed again. She continued to have gradual improvement and was able to get out of bed by February and by March 2022 she contracted another viral infection from her kids but she tested negative for COVID and she didn't experience worsening of her symptoms after that infection.  On March 25th she had a tilt table testing at hospital. The testing showed inappropriate sinus tachycardia
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Mobility decreased, Movement disorder, Palpitations, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test negative
Clinical narrative: This is a 36 year old previously healthy woman. She had COVID Vaccine (Pfizer, first dose) on April 2021 and immediately after the vaccination, she started experiencing dizziness and ringing sound in her ears. She went back home and these symptoms continued to get worse.  Ten days after vaccination, she felt very tired, dizzy and heart racing then she fell down but didn't pass out and was transferred to ER. At the ER she had a lot of work up done and was normal and was given some IV fluids then sent home. After going home she continued to have worsening symptoms and went to the ER again and repeated work up was negative and was sent home. She continued to feel worse and from April to June 2021 she was staying at bed and not able to walk or move. On August, she started to improve gradually  and be able to get out of bed and do some upright activities. On November she contracted a viral infection form her kids but didn't get tested for COVID as her symptoms looked like regular flu and she had a relapse with worsening symptoms and being bedridden. By beginning of December 2021 she started to experience some improvement in her symptoms and went to see a physical therapist who instructed her to do squatting exercises and once she started doing it, her symptom got worse again and spent the whole month of January 2022 in bed again. She continued to have gradual improvement and was able to get out of bed by February and by March 2022 she contracted another viral infection from her kids but she tested negative for COVID and she didn't experience worsening of her symptoms after that infection.  On March 25th she had a tilt table testing at hospital. The testing showed inappropriate sinus tachycardia
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sinus tachycardia, Tilt table test positive, Tinnitus, Viral infection
Clinical narrative: This is a 36 year old previously healthy woman. She had COVID Vaccine (Pfizer, first dose) on April 2021 and immediately after the vaccination, she started experiencing dizziness and ringing sound in her ears. She went back home and these symptoms continued to get worse.  Ten days after vaccination, she felt very tired, dizzy and heart racing then she fell down but didn't pass out and was transferred to ER. At the ER she had a lot of work up done and was normal and was given some IV fluids then sent home. After going home she continued to have worsening symptoms and went to the ER again and repeated work up was negative and was sent home. She continued to feel worse and from April to June 2021 she was staying at bed and not able to walk or move. On August, she started to improve gradually  and be able to get out of bed and do some upright activities. On November she contracted a viral infection form her kids but didn't get tested for COVID as her symptoms looked like regular flu and she had a relapse with worsening symptoms and being bedridden. By beginning of December 2021 she started to experience some improvement in her symptoms and went to see a physical therapist who instructed her to do squatting exercises and once she started doing it, her symptom got worse again and spent the whole month of January 2022 in bed again. She continued to have gradual improvement and was able to get out of bed by February and by March 2022 she contracted another viral infection from her kids but she tested negative for COVID and she didn't experience worsening of her symptoms after that infection.  On March 25th she had a tilt table testing at hospital. The testing showed inappropriate sinus tachycardia
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysarthria, Facial paralysis, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Approximately 2 hours after receiving vaccine (6pm), patient experienced stroke-like symptoms where he had trouble speaking and could not move. Patient laid in bed and slept for a couple days.  He is concerned with having seizures since Moderna covid19 vaccine. Patient did not go to ER or urgent care or seek medical help.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Approximately 2 hours after receiving vaccine (6pm), patient experienced stroke-like symptoms where he had trouble speaking and could not move. Patient laid in bed and slept for a couple days.  He is concerned with having seizures since Moderna covid19 vaccine. Patient did not go to ER or urgent care or seek medical help.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Hyperhidrosis, Hypoaesthesia, Limb mass, Nervous system disorder
Clinical narrative: Approximately 2 hours after receiving vaccine (6pm), patient experienced stroke-like symptoms where he had trouble speaking and could not move. Patient laid in bed and slept for a couple days.  He is concerned with having seizures since Moderna covid19 vaccine. Patient did not go to ER or urgent care or seek medical help.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: Approximately 2 hours after receiving vaccine (6pm), patient experienced stroke-like symptoms where he had trouble speaking and could not move. Patient laid in bed and slept for a couple days.  He is concerned with having seizures since Moderna covid19 vaccine. Patient did not go to ER or urgent care or seek medical help.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aphasia, Bedridden, Hypersomnia, Movement disorder, Neurological symptom
Clinical narrative: Approximately 2 hours after receiving vaccine (6pm), patient experienced stroke-like symptoms where he had trouble speaking and could not move. Patient laid in bed and slept for a couple days.  He is concerned with having seizures since Moderna covid19 vaccine. Patient did not go to ER or urgent care or seek medical help.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Brain neoplasm, General physical health deterioration, Loss of consciousness, Neurological symptom, Seizure
Clinical narrative: Approximately 2 hours after receiving vaccine (6pm), patient experienced stroke-like symptoms where he had trouble speaking and could not move. Patient laid in bed and slept for a couple days.  He is concerned with having seizures since Moderna covid19 vaccine. Patient did not go to ER or urgent care or seek medical help.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Spinal fracture
Clinical narrative: Approximately 2 hours after receiving vaccine (6pm), patient experienced stroke-like symptoms where he had trouble speaking and could not move. Patient laid in bed and slept for a couple days.  He is concerned with having seizures since Moderna covid19 vaccine. Patient did not go to ER or urgent care or seek medical help.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Visual impairment
Clinical narrative: I experienced a Central Retina Artery Occlusion (CRAO) shortly after the 2nd booster was administered. I have lost the site in my right eye. Per Ophthalmologist, I will no regain my sight.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, C-reactive protein normal, Echocardiogram, Laboratory test normal, Optic disc haemorrhage
Clinical narrative: I experienced a Central Retina Artery Occlusion (CRAO) shortly after the 2nd booster was administered. I have lost the site in my right eye. Per Ophthalmologist, I will no regain my sight.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Optic neuritis, Retinal artery occlusion, Retinogram abnormal, Ultrasound Doppler normal, Visual field tests abnormal
Clinical narrative: I experienced a Central Retina Artery Occlusion (CRAO) shortly after the 2nd booster was administered. I have lost the site in my right eye. Per Ophthalmologist, I will no regain my sight.
Sex: M
Vaccine: UNK, COVID19
Symptoms: Asthenia, Chills
Clinical narrative: Extreme weakness; Severe shivering for 12 to 14 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 29Apr2022 at 04:15 as dose 4 (booster), single (Lot number: PF4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 29Apr2022 at 09:15, outcome "recovering", described as "Extreme weakness"; CHILLS (non-serious) with onset 29Apr2022 at 09:15, outcome "recovering", described as "Severe shivering for 12 to 14 hours". Therapeutic measures were not taken as a result of asthenia, chills.  Additional information: The clinical course was reported as patient age group: elderly (65 years), current age: 76. Patient had received dose more than 3. The patient had not received other vaccine in 4 weeks. Patient had no covid prior vaccination and not had covid tested posted vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: she had localized pain on the injection site after receiving the 4 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that patient had no allergies to medications, food and other products. Patient had no history of COVID-19. Patient had no acute or chronic illness at time of vaccination.  Concomitant products included CANNABIDIOL (CBD OIL), SIMVASTATIN and FAMOTIDINE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses). At the time of the report, VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient administered dose 3 on 08-Nov-2021 with batch numbers R89350 and 1822809.  It was reported that patient did not take other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-554212, MOD-2022-554221, MOD-2022-554223 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Muscular weakness, Pain in extremity, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: she had localized pain on the injection site after receiving the 4 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that patient had no allergies to medications, food and other products. Patient had no history of COVID-19. Patient had no acute or chronic illness at time of vaccination.  Concomitant products included CANNABIDIOL (CBD OIL), SIMVASTATIN and FAMOTIDINE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses). At the time of the report, VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient administered dose 3 on 08-Nov-2021 with batch numbers R89350 and 1822809.  It was reported that patient did not take other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-554212, MOD-2022-554221, MOD-2022-554223 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Hypothyroidism, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "had his 3 Pfizer Covid vaccines, then got the Covid 19 virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: he got Covid-19 on New Year's weekend. Caller stated that he got 3 doses of the Pfizer Covid-19 Vaccine. Reaction / Event as Reported by the Primary Source for Translation: had his 3 Pfizer Covid vaccines, then got the Covid-19 virus. Caller stated that on his 1st dose, he experienced tiredness. During his 3rd dose, he experienced pain under left armpit and pain on the glands in his throat. When he consulted with his doctor, they found that his thyroid did not produce enough hormones. Caller stated that he is in a hypothyroid state. Caller is looking into getting his 4th dose. Caller wanted to check if thyroid issues will have an effect with the Pfizer Covid-19 Vaccine. Caller also wanted to check if there is information on the vaccine causing thyroid issues. States his 3rd shot was in Oct2021, and he got Covid-19 on New Years weekend. He has been having lingering symptoms, one of which being his thyroid is not producing enough hormone, so he is hypothyroid. He is hoping that maybe the 4th shot will help that improve. Declined to complete the report. States that he is thinking about getting the 4th shot this weekend but wants to make sure it won't make his thyroid issue worse. Requests to be transferred. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.