chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Blood test, Dizziness, Dyspnoea, Fatigue, Haematoma
Clinical narrative: Bleeding under the skin in foot and hand accompanied by some dizzyness, shortness of breath, fatigue. Pain and numbness at sites of hematomas. Saw primary care doctor who evaluated and referred me to hematologist. Saw Oncology who ordered lab work and when reviewing the results with me communicated no known cause for the hematomas which were by then resolved and have not recurred.  Additionally, my menstrual period was due around 10/09/21, the same day of my vaccinations. I did not get my period when it was due, and the start of my next menstrual cycle was 126 days later, on 01/16/2022.
Age: 49.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Haemorrhage subcutaneous, Hypoaesthesia, Laboratory test, Menstruation delayed, Menstruation irregular
Clinical narrative: Bleeding under the skin in foot and hand accompanied by some dizzyness, shortness of breath, fatigue. Pain and numbness at sites of hematomas. Saw primary care doctor who evaluated and referred me to hematologist. Saw Oncology who ordered lab work and when reviewing the results with me communicated no known cause for the hematomas which were by then resolved and have not recurred.  Additionally, my menstrual period was due around 10/09/21, the same day of my vaccinations. I did not get my period when it was due, and the start of my next menstrual cycle was 126 days later, on 01/16/2022.
Age: 49.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Pain
Clinical narrative: Bleeding under the skin in foot and hand accompanied by some dizzyness, shortness of breath, fatigue. Pain and numbness at sites of hematomas. Saw primary care doctor who evaluated and referred me to hematologist. Saw Oncology who ordered lab work and when reviewing the results with me communicated no known cause for the hematomas which were by then resolved and have not recurred.  Additionally, my menstrual period was due around 10/09/21, the same day of my vaccinations. I did not get my period when it was due, and the start of my next menstrual cycle was 126 days later, on 01/16/2022.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Fatigue, Increased upper airway secretion
Clinical narrative: 12 hours after injection experienced fever chills/ flu symptoms/ lasted 1 day.   Shortly after that some intermitent cough ( am avid runner) fatigue. On 5/2/22 tested neg for covid just curious as I had some mild symptoms. On 5/3/22 A ripid onset sore throat and dry cough that progressessed over several days. Shortness of breathe. Unable to find relief especially at night. Bronchial cough. 3 virtual visits and z pak prednizone cough pills minimal affect. Chesht xray neg. Inhaller new antibiotic. Slow progress. Urgent care on 5/14/22 Confirmed bronchial congestion O2 100percent. Difficulty clearing airway. Advised to stop antibiotic after 1 day Inhaler. Very Unusual for me. I feel like something else is occurring here. Possibly adverse reaction long haul vaccine. Still hoping to improve.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Lower respiratory tract congestion, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 12 hours after injection experienced fever chills/ flu symptoms/ lasted 1 day.   Shortly after that some intermitent cough ( am avid runner) fatigue. On 5/2/22 tested neg for covid just curious as I had some mild symptoms. On 5/3/22 A ripid onset sore throat and dry cough that progressessed over several days. Shortness of breathe. Unable to find relief especially at night. Bronchial cough. 3 virtual visits and z pak prednizone cough pills minimal affect. Chesht xray neg. Inhaller new antibiotic. Slow progress. Urgent care on 5/14/22 Confirmed bronchial congestion O2 100percent. Difficulty clearing airway. Advised to stop antibiotic after 1 day Inhaler. Very Unusual for me. I feel like something else is occurring here. Possibly adverse reaction long haul vaccine. Still hoping to improve.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Severe vomiting, fever, body ache, headache for 2 days. I did not receive treatment, just waited it out.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Headache, joint pain, chills, fatigue, dizziness, shortness of breath
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache, joint pain, chills, fatigue, dizziness, shortness of breath
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: pt developed swelling and hives near injection site
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Biopsy liver abnormal, Chromaturia, Eating disorder, Faeces pale
Clinical narrative: Nausea and vomiting, inability to eat normal size meals. Severe jaundice and icterus, dark urine and pale stools.  Admitted to hospital on 12/23/2021. Discharged on 12/28/2021. Currently taking Budesonide 3mg daily due to diagnosis of autoimmune hepatitis.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Jaundice, Nausea, Vomiting
Clinical narrative: Nausea and vomiting, inability to eat normal size meals. Severe jaundice and icterus, dark urine and pale stools.  Admitted to hospital on 12/23/2021. Discharged on 12/28/2021. Currently taking Budesonide 3mg daily due to diagnosis of autoimmune hepatitis.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Patient had significant redness and some swelling/tenderness (not with movement but to the touch) the day following the vaccine. I spoke to her two and three days after vaccination and she was having some improvement in symptoms and has not sought medical treatment.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Cough, Hernia, Loss of consciousness
Clinical narrative: Chill all night leading to cough to the extreme of passing out  Hospital found lung colapsed, mass in lung, torn herniaon rt side from coughing lower rt lung collapse.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumothorax, Positron emission tomogram, Pulmonary mass, X-ray
Clinical narrative: Chill all night leading to cough to the extreme of passing out  Hospital found lung colapsed, mass in lung, torn herniaon rt side from coughing lower rt lung collapse.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Sensory loss
Clinical narrative: injection site area skin and underlying muscle feel numb to the touch.  Not completely numb, but significant reduction in sensation when rubbed or otherwise stimulated.  About 5" in diameter centering on injection site.  All injections in series given in the same location.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Persistent loud tinnitus in the left ear
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events occurred; however, when speaking to the mother it was stated that she was immunocompromised.  After giving the patient the dose and speaking with the mother, it was discovered that the patient was not immunocompromised.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arteriogram coronary normal, Electrocardiogram abnormal, Electrocardiogram ambulatory normal, Fibrin D dimer increased, Heart rate irregular
Clinical narrative: New onset of significant sinus arrythmia palpitations became significant on 4/14/22 after #4 vaccine of 4/8/21.   Onset 4/13.  Sx severe enough to trigger urgent care evaluation.  Very symptomatic irregular heart beat found to be sinus arrythmia.  Condition was easily noticed on EKG's and physical exams on 4/14/22 pm and 4/15/22 am.  D-Dimer elevation of 1.82 (<0.52).  This triggered a CT angiogram which was normal.  Sx resolved after 4/15/22.  Holter was essentially normal 4/22-4/24/22.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Palpitations, Sinus arrhythmia
Clinical narrative: New onset of significant sinus arrythmia palpitations became significant on 4/14/22 after #4 vaccine of 4/8/21.   Onset 4/13.  Sx severe enough to trigger urgent care evaluation.  Very symptomatic irregular heart beat found to be sinus arrythmia.  Condition was easily noticed on EKG's and physical exams on 4/14/22 pm and 4/15/22 am.  D-Dimer elevation of 1.82 (<0.52).  This triggered a CT angiogram which was normal.  Sx resolved after 4/15/22.  Holter was essentially normal 4/22-4/24/22.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under arm where vaccine administered
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient received 2 Moderna booster doses during the vaccine clinic as the patient had 2 different consent forms and went to both of the vaccinators so it was unknown to the vaccinators that the patient had already received a vaccine in that same day.  The booster vaccine doses were given in different arms: 1 in the left deltoid and 1 in the right deltoid.  When discovered, the information was given to the Long-Term Care facility and she was going to contact the primary physician.  At the time which was 2 days later, the patient was doing fine.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased
Clinical narrative: Patient describes elevated heart rate starting about 2 am the morning after the vaccination. Heart rate remained elevated for almost 24 hours before subsiding without intervention. Heart rate hovered around 105 bpm until resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral disorder, Headache, Pyrexia, Tinnitus, Tremor
Clinical narrative: Patient describes elevated heart rate starting about 2 am the morning after the vaccination. Heart rate remained elevated for almost 24 hours before subsiding without intervention. Heart rate hovered around 105 bpm until resolved.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Skin weeping
Clinical narrative: Redness, pain, swelling, and rash localized to the injection site. There was some oozing from the rash as well. Patient had a case of shingles in the past with similar presentation on his leg.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Decreased appetite, Fatigue, Irritability, Lacrimation increased
Clinical narrative: Watery eyes, runny nose, cough, mild fever, irritability, decreased appetite, tiredness, mild rash
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Watery eyes, runny nose, cough, mild fever, irritability, decreased appetite, tiredness, mild rash
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: headache, increased muscle pain,, chills, nausea and vomitin fever ,
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: headache, increased muscle pain,, chills, nausea and vomitin fever ,
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Renal artery thrombosis
Clinical narrative: A blood clot in each of my renal arteries, as a result I am now taking the following medications: Warfarin 2.5 mg, Hydrochloroth-Iazide 12.5 mg, and Amlodipine Besylate 5mg.  It was determined that blood clots were not caused by heart issues or any type of blood disorder.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Pt  passed out
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Ear pain, Mastication disorder, Pain in jaw, Temporomandibular joint syndrome
Clinical narrative: I've had R jaw pain since the evening of the shot (Friday) that made it  painful to chew or open my mouth all the way. I still have it today (Sunday) and I also have some pain in my ear, but it is bearable, just annoying.  (I only have had very slight pain at the vaccine site.) I couldn't think of any other reason for this pain, so I was curious to see if there was any correlation between the vaccine and tmj pain and discovered that there is, that's why I'm reporting it.  I hope it doesn't get worse...
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I've had R jaw pain since the evening of the shot (Friday) that made it  painful to chew or open my mouth all the way. I still have it today (Sunday) and I also have some pain in my ear, but it is bearable, just annoying.  (I only have had very slight pain at the vaccine site.) I couldn't think of any other reason for this pain, so I was curious to see if there was any correlation between the vaccine and tmj pain and discovered that there is, that's why I'm reporting it.  I hope it doesn't get worse...
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given vaccine with beyond use date of 4/14/22 on 4/19/22
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Brain scan normal, Laboratory test normal, Loss of consciousness, Transient ischaemic attack
Clinical narrative: The patient stated she had what she called a "mini stroke" while at the hospital with her daughter, who was having a baby.  She passed out and when she came around she had a hard time talking.  The doctor ran test on her for a stroke but nothing showed up the the tests.  This was approximately a week after having the covid  shot
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient given vaccine on 4/19/22 with a beyond use date of 4/14/2022. No adverse reaction was reported. Patient has not been re-vaccinated yet. She has been notified of error and asked to revaccinate per our consultation with Pfizer regarding temperature excursion.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Client presented to the COVID-19 Vaccination Clinic on 1/20/2022 for her first COVID-19 vaccine, but she is documented as having received the adult formulation of Pfizer with the lot number FJ5683, which would be an inappropriate vaccine type for her age. This error was one of several found as part of a routine audit, the majority of which were determined to be simple documentation errors and not vaccine administration errors. However, the client?s guardian was unable to be contacted in order to determine which vaccine was actually received (please see below for an outline of attempts to reach the client?s guardian). The possibility of a vaccine administration error cannot be ruled out at this time. Attempts to contact: ? Called with voicemail left on 2/24/2022 ? Called with voicemail left on 2/25/2022 ? Called with voicemail left on 3/8/2022 ? Emailed on 3/28/2022 ? Physical letter sent on 4/13/2022 ? Called with voicemail left on 5/8/2022 All staff at the COVID-19 Vaccination Clinic have been educated on a procedure designed to reduce vaccination and/or documentation errors: vaccination staff ask clients to confirm their name and DOB and then respond by speaking the client?s age aloud and verbally confirming which vaccine the client is receiving. They will also verbally confirm the vaccine type aloud when they choose the vaccine type from the drop-down menu. The staff member who made the preponderance of the documentation errors was also individually coached regarding the accuracy of their vaccination recording practices.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: Excessive bleeding and swelling at site of injection immediately after IM injection upper left deltoid muscle about 3:15 PM on May 15, 2022.  Changed dressing to 2 standard bandages along with ice pack application for 15 minutes. Patient did NOT have dizziness, faintness nor abnormal pain. Patient received Adacel immunization in right upper deltoid minutes prior without any observed reactions. Patient remaind seating for 15 minutes with daughter and left with out complaint thereafter.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Client presented to the COVID-19 Vaccination Clinic on 1/19/2022 for his second COVID-19 vaccine, but he is documented as having received the adult formulation of Pfizer with the lot number FJ5683, which would be an inappropriate vaccine type for his age. This error was one of several found as part of a routine audit, the majority of which were determined to be simple documentation errors and not vaccine administration errors.  However, the facility has been unable to determine which vaccine was actually received due to an inability to get in meaningful contact with the client's guardians. They were called and reached once, but they reported that they were busy and would call back, although they did not actually do so. In all, they were called three times (though voicemails were unable to be left, as the voicemail box was full), they were also emailed on 3/28/2022 and were sent a physical letter on 4/13/2022. The possibility of a vaccine administration error cannot be ruled out at this time. All staff at the COVID-19 Vaccination Clinic have been educated on a procedure designed to reduce vaccination and/or documentation errors: vaccination staff ask clients to confirm their name and DOB and then respond by speaking the client's age aloud and verbally confirming which vaccine the client is receiving. They will also verbally confirm the vaccine type aloud when they choose the vaccine type from the drop-down menu. The staff member who made the preponderance of the documentation errors was also individually coached regarding the accuracy of their vaccination recording practices.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea, Impaired work ability, Inflammation, Oesophageal disorder
Clinical narrative: Difficulty breathing which is getting worse.  Had to retire as could no longer do job.  Breathing and lung compactor continues to decline.  My doctor says result of inflammation but nothing has helped.  Current test show 50% capacity on exhale.  May also have esophagus issues as a result due for endoscopy with next month.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary function test abnormal, Retirement
Clinical narrative: Difficulty breathing which is getting worse.  Had to retire as could no longer do job.  Breathing and lung compactor continues to decline.  My doctor says result of inflammation but nothing has helped.  Current test show 50% capacity on exhale.  May also have esophagus issues as a result due for endoscopy with next month.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes normal, Blood test normal, Chronic spontaneous urticaria, Liver function test normal, Rash
Clinical narrative: On 1/9/2022, 10 days after Covid booster shot, I started to develop whole body rashes/hives with unknown triggers.  In the first few days the rashes were especially red, itchy, covering the whole body.  Eating high histamine food aggrevated the condition even more, to the point I had to call the emergency room.  The only way to calm the skin down was to take Zyrtec.    Since then, for the last 4+ months up till now, almost everyday I develop some kind of rashes with unknown triggers.  It migrates around the body, mostly around neck, waist and back.  The onset time of the rashes typically start early in the morning after wakeup, early evening before dinner and after showers.  The rash typically lasts 1-2 hours. For these months, I'm not able to pinpoint the exact cause of the rashes.  It could occur while I'm at home, while in store or while in a hotel room.  Food is not the cause of the rashes, but the aggrevator.  As a result, I have take out any high histamine foods out of my diet (seafood, shellfish, beef, chicken, tomato, eggplant, garlic, onion, soysauce, tree nuts, chocolate, etc. etc.) and restrict myself to the very limited list of veggies.  I have consulted 4 different doctors.  None of them is able to pinpoint the cause.   I'm part of an online group which has 6500 members who have similar symptoms after covid vaccines.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Renal function test normal, Thyroid function test normal, Urticaria
Clinical narrative: On 1/9/2022, 10 days after Covid booster shot, I started to develop whole body rashes/hives with unknown triggers.  In the first few days the rashes were especially red, itchy, covering the whole body.  Eating high histamine food aggrevated the condition even more, to the point I had to call the emergency room.  The only way to calm the skin down was to take Zyrtec.    Since then, for the last 4+ months up till now, almost everyday I develop some kind of rashes with unknown triggers.  It migrates around the body, mostly around neck, waist and back.  The onset time of the rashes typically start early in the morning after wakeup, early evening before dinner and after showers.  The rash typically lasts 1-2 hours. For these months, I'm not able to pinpoint the exact cause of the rashes.  It could occur while I'm at home, while in store or while in a hotel room.  Food is not the cause of the rashes, but the aggrevator.  As a result, I have take out any high histamine foods out of my diet (seafood, shellfish, beef, chicken, tomato, eggplant, garlic, onion, soysauce, tree nuts, chocolate, etc. etc.) and restrict myself to the very limited list of veggies.  I have consulted 4 different doctors.  None of them is able to pinpoint the cause.   I'm part of an online group which has 6500 members who have similar symptoms after covid vaccines.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care
Clinical narrative: Unknown. Unable to contact this case as he remains in ICU, admitted 05/09/2022.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: Right hand index finger started involuntary jerking
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Dysphagia, Exercise tolerance decreased, Fatigue
Clinical narrative: Sore arm immediately that lasted for 3 days. First night painful could not sleep. As of this date I continue to experience fatigue, headaches, light pressure back of the head, appetite is improved over the last couple of days. Energy level is low especially if I move around or try and exercise. One night difficulty swallowing.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Headache, Immediate post-injection reaction, Insomnia, Pain in extremity
Clinical narrative: Sore arm immediately that lasted for 3 days. First night painful could not sleep. As of this date I continue to experience fatigue, headaches, light pressure back of the head, appetite is improved over the last couple of days. Energy level is low especially if I move around or try and exercise. One night difficulty swallowing.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed tinnitus bilaterally 15 days after this vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Delirium, Headache
Clinical narrative: Three days of high fever (102.6 at its highest). Delirium.  Body aches, chills, headaches, stuffy nose and sinuses, bad cough, flem and loss of appetite. Treatment: regular administration of tylenol, fluids. My wife and a good friend have had similar reactions.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Productive cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: Three days of high fever (102.6 at its highest). Delirium.  Body aches, chills, headaches, stuffy nose and sinuses, bad cough, flem and loss of appetite. Treatment: regular administration of tylenol, fluids. My wife and a good friend have had similar reactions.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Bone densitometry, Connective tissue disorder
Clinical narrative: 3-4 days - Extreme fatigue, nausea, fever, couldn't eat, slept day and night On-going 6-7 months - fatigue, muscle, joint, connective tissue pain, unable to lift even blanket so slept on couch, loss of strength Still - fatigue unpredictable resulting in being on the couch and sleeping during the day, continued muscle, joint, connective tissue pain although less than above, loss of strength is on-going but less than above.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Hypersomnia, Magnetic resonance imaging, Mobility decreased
Clinical narrative: 3-4 days - Extreme fatigue, nausea, fever, couldn't eat, slept day and night On-going 6-7 months - fatigue, muscle, joint, connective tissue pain, unable to lift even blanket so slept on couch, loss of strength Still - fatigue unpredictable resulting in being on the couch and sleeping during the day, continued muscle, joint, connective tissue pain although less than above, loss of strength is on-going but less than above.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Ultrasound scan
Clinical narrative: 3-4 days - Extreme fatigue, nausea, fever, couldn't eat, slept day and night On-going 6-7 months - fatigue, muscle, joint, connective tissue pain, unable to lift even blanket so slept on couch, loss of strength Still - fatigue unpredictable resulting in being on the couch and sleeping during the day, continued muscle, joint, connective tissue pain although less than above, loss of strength is on-going but less than above.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Insomnia, Pyrexia
Clinical narrative: Started feeling very tired the evening after the injection. Couldn't sleep the night after and on Sunday about 48 hrs after shot at had bad chills, fever of 101°, bad joint pain in legs and hips.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vertigo
Clinical narrative: Vertigo, dizziness, imbalance lasting now over 3 weeks.  Constant light-headedness, and dizziness upon lifting head.
Age: 39.0
Sex: M
Vaccine: COVID19, MNQ
Symptoms: Cellulitis, Haematoma, Lymphadenopathy, Pyrexia, Subcutaneous abscess
Clinical narrative: Left axililla cellulitis abscess,, fever, soft >4cm hematoma in area of left axillia lymph node presenting 24 hours post vaccine administration
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was given moderna which is outside the age group that is authorized
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Pt fainted after getting up from seat and taking a step after receiving the covid vaccine
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Laboratory test
Clinical narrative: Headaches have begun to plague me since receiving Moderna booster. I think the sugar is not a long enough preservative so after a few months it wore off and the COVID infected me.
Age: 74.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Amnesia, Gait inability, Tremor
Clinical narrative: I called patient on 5/15/22 as a reminder for her second Shingrix dose.  She then said that a month after administration she developed shaking, the inability to walk, and memory loss.  She had also received Boostrix that day as well.  She also stated she was just released from the hospital after a 6 day stay.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Catheterisation cardiac abnormal, Chest pain, Computerised tomogram
Clinical narrative: Began experiencing chest pains and shortness of breath 2 weeks after the second shot. Pain became intolerable and was alarming so I made appointment with my primary care physician. The EKG was abnormal so a CT scan was ordered.  The discomfort continued for 2 days until pains grew extreme and had to go to the ER. Was admitted for 5 days and was told I had a miocardial infarction after a series of tests. A catheter procedure was done to place a stent in my LAD artery which was 90 percent blocked.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Coronary artery occlusion, Dyspnoea, Electrocardiogram abnormal, Myocardial infarction
Clinical narrative: Began experiencing chest pains and shortness of breath 2 weeks after the second shot. Pain became intolerable and was alarming so I made appointment with my primary care physician. The EKG was abnormal so a CT scan was ordered.  The discomfort continued for 2 days until pains grew extreme and had to go to the ER. Was admitted for 5 days and was told I had a miocardial infarction after a series of tests. A catheter procedure was done to place a stent in my LAD artery which was 90 percent blocked.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Positron emission tomogram
Clinical narrative: Began experiencing chest pains and shortness of breath 2 weeks after the second shot. Pain became intolerable and was alarming so I made appointment with my primary care physician. The EKG was abnormal so a CT scan was ordered.  The discomfort continued for 2 days until pains grew extreme and had to go to the ER. Was admitted for 5 days and was told I had a miocardial infarction after a series of tests. A catheter procedure was done to place a stent in my LAD artery which was 90 percent blocked.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Pain
Clinical narrative: Chills, fever, achiness, headache, severe low back pain, fatigue
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, fever, achiness, headache, severe low back pain, fatigue
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dry skin, Erythema, Pruritus, Psoriasis
Clinical narrative: 1. No previous history with any skin condition 2. Onsite of Psorarias secondary to Booster Shot of Pfizer mRNA 3. Started experiencing redness under breasts, circle dry patches on neck and forehead. Attempted to treat with OTC Hydrocortisone, .1% 2x/day, which seemed to provide some relief - but not for long.  4. More dark circles, with raised bumps, scalp itching, and scaling continued to the point where I had over 30 patches of dry spots on my  torso, back, neck, ears, buttocks, and right arm. 5. As things continued to get progressively worse, I went to see my PCP and he diagnosed me with the onset of psoriasis resulting from mRNA Pfizer booster.   6. by 5/14/22 - 75% of my hair has now fallen out due to dry patches, scalp flaking.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Skin discolouration, Skin exfoliation
Clinical narrative: 1. No previous history with any skin condition 2. Onsite of Psorarias secondary to Booster Shot of Pfizer mRNA 3. Started experiencing redness under breasts, circle dry patches on neck and forehead. Attempted to treat with OTC Hydrocortisone, .1% 2x/day, which seemed to provide some relief - but not for long.  4. More dark circles, with raised bumps, scalp itching, and scaling continued to the point where I had over 30 patches of dry spots on my  torso, back, neck, ears, buttocks, and right arm. 5. As things continued to get progressively worse, I went to see my PCP and he diagnosed me with the onset of psoriasis resulting from mRNA Pfizer booster.   6. by 5/14/22 - 75% of my hair has now fallen out due to dry patches, scalp flaking.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Hepatic enzyme increased, Influenza like illness
Clinical narrative: Fever, chills, headache, fatigue  Flu like symptoms 3 days
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Platelet count decreased, Pyrexia, Rash
Clinical narrative: Fever, chills, headache, fatigue  Flu like symptoms 3 days
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted right after receiving the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood culture negative, COVID-19, Death, Intensive care
Clinical narrative: Patient tested positive for COVID 19 on 8/26/2021, symptoms starting on 8/23/2021, was originally admitted to the Medical Center on 8/31/2021 due to covid symptoms and acute respiratory failure, placed in ICU on vapotherm and BiPap and discharged on home oxygen.  During that hospitalization patient received remdesivir, baricitnib and steroid therapy.  Patient was admitted to another medical center with acute hypoxic respiratory failure and concerns for superadded bacterial infection.  Patient was started on broad-spectrum IV antibiotic therapy, IV solu-mederol, patient was admitted to ICU team.  Patient continued to do poorly and was noted on and off fevers, started on IV fluconazole, IV acylovir, and IV cefepime, blood cultures were negative.  Patient was noted to have SVT, and started on metoprolol, Cardizem drip.  Patient continued to do poorly, and was made a DNR.  Patient expired on 10/11/2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Positive airway pressure therapy, Pyrexia, SARS-CoV-2 test positive, Supraventricular tachycardia
Clinical narrative: Patient tested positive for COVID 19 on 8/26/2021, symptoms starting on 8/23/2021, was originally admitted to the Medical Center on 8/31/2021 due to covid symptoms and acute respiratory failure, placed in ICU on vapotherm and BiPap and discharged on home oxygen.  During that hospitalization patient received remdesivir, baricitnib and steroid therapy.  Patient was admitted to another medical center with acute hypoxic respiratory failure and concerns for superadded bacterial infection.  Patient was started on broad-spectrum IV antibiotic therapy, IV solu-mederol, patient was admitted to ICU team.  Patient continued to do poorly and was noted on and off fevers, started on IV fluconazole, IV acylovir, and IV cefepime, blood cultures were negative.  Patient was noted to have SVT, and started on metoprolol, Cardizem drip.  Patient continued to do poorly, and was made a DNR.  Patient expired on 10/11/2021.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Fatigue, Guillain-Barre syndrome, Muscular weakness, Neurological examination
Clinical narrative: Guillain-Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Patient never had COVID diagnosis.  The patient's past medical history included Guillain-Barre syndrome (She had Guillain-Barre syndrome at 7 years old for a year. It took a whole year to recover and has not come back since.).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant). The patient was treated with Physical therapy (Treatment included physical therapy.) for Guillain-Barre syndrome. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Patient went to multiple doctors.  Company Comment: This spontaneous case concerns a 71-year-old female patient, with relevant medical history of Guillain-Barre syndrome, who experienced the unexpected serious (medically significant) AESI of Guillain-Barre syndrome. The patient stated that a couple of days after vaccination her thigh got very weak and eventually had pain. A week later her left arm developed weakness. She was diagnosed with Guillain-Barre syndrome approximately 6 months after receiving the first dose of mRNA-1273 Vaccine. The outcome of the event was reported as not resolved. The patient's medical history of Guillain-Barre syndrome, remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-109744 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71-year-old female patient, with relevant medical history of Guillain-Barre syndrome, who experienced the unexpected serious (medically significant) AESI of Guillain-Barre syndrome. The patient stated that a couple of days after vaccination her thigh got very weak and eventually had pain. A week later her left arm developed weakness. She was diagnosed with Guillain-Barre syndrome approximately 6 months after receiving the first dose of mRNA-1273 Vaccine. The outcome of the event was reported as not resolved. The patient's medical history of Guillain-Barre syndrome, remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Guillain-Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Patient never had COVID diagnosis.  The patient's past medical history included Guillain-Barre syndrome (She had Guillain-Barre syndrome at 7 years old for a year. It took a whole year to recover and has not come back since.).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant). The patient was treated with Physical therapy (Treatment included physical therapy.) for Guillain-Barre syndrome. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Patient went to multiple doctors.  Company Comment: This spontaneous case concerns a 71-year-old female patient, with relevant medical history of Guillain-Barre syndrome, who experienced the unexpected serious (medically significant) AESI of Guillain-Barre syndrome. The patient stated that a couple of days after vaccination her thigh got very weak and eventually had pain. A week later her left arm developed weakness. She was diagnosed with Guillain-Barre syndrome approximately 6 months after receiving the first dose of mRNA-1273 Vaccine. The outcome of the event was reported as not resolved. The patient's medical history of Guillain-Barre syndrome, remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-109744 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71-year-old female patient, with relevant medical history of Guillain-Barre syndrome, who experienced the unexpected serious (medically significant) AESI of Guillain-Barre syndrome. The patient stated that a couple of days after vaccination her thigh got very weak and eventually had pain. A week later her left arm developed weakness. She was diagnosed with Guillain-Barre syndrome approximately 6 months after receiving the first dose of mRNA-1273 Vaccine. The outcome of the event was reported as not resolved. The patient's medical history of Guillain-Barre syndrome, remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Patient never had COVID diagnosis.  The patient's past medical history included Guillain-Barre syndrome (She had Guillain-Barre syndrome at 7 years old for a year. It took a whole year to recover and has not come back since.).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant). The patient was treated with Physical therapy (Treatment included physical therapy.) for Guillain-Barre syndrome. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Patient went to multiple doctors.  Company Comment: This spontaneous case concerns a 71-year-old female patient, with relevant medical history of Guillain-Barre syndrome, who experienced the unexpected serious (medically significant) AESI of Guillain-Barre syndrome. The patient stated that a couple of days after vaccination her thigh got very weak and eventually had pain. A week later her left arm developed weakness. She was diagnosed with Guillain-Barre syndrome approximately 6 months after receiving the first dose of mRNA-1273 Vaccine. The outcome of the event was reported as not resolved. The patient's medical history of Guillain-Barre syndrome, remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-109744 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71-year-old female patient, with relevant medical history of Guillain-Barre syndrome, who experienced the unexpected serious (medically significant) AESI of Guillain-Barre syndrome. The patient stated that a couple of days after vaccination her thigh got very weak and eventually had pain. A week later her left arm developed weakness. She was diagnosed with Guillain-Barre syndrome approximately 6 months after receiving the first dose of mRNA-1273 Vaccine. The outcome of the event was reported as not resolved. The patient's medical history of Guillain-Barre syndrome, remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood cholesterol, Hypocholesterolaemia, Therapeutic response unexpected
Clinical narrative: drowsiness; sore arm; Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had Covid in 2020 and first initial drop in cholesterol was noticed) in 2020. Concurrent medical conditions included Drug allergy and High cholesterol.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level). At the time of the report, SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Low density lipoprotein: 176 (High) 176. In 2021, Low density lipoprotein: decreased (Low) cholesterol levels have decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The low-density lipoprotein Cholesterol was at 176 initially and the last test done 10 days after the vaccine showed significant decrease in cholesterol levels. The patient reported that there were blood tests and medical records to prove the correlation.  No treatment medication were provided.   This case was linked to MOD-2022-564739, MOD-2022-564749, MOD-2022-564750 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Low density lipoprotein, Low density lipoprotein decreased, Pain in extremity, SARS-CoV-2 test false negative, Somnolence
Clinical narrative: drowsiness; sore arm; Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had Covid in 2020 and first initial drop in cholesterol was noticed) in 2020. Concurrent medical conditions included Drug allergy and High cholesterol.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level). At the time of the report, SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Low density lipoprotein: 176 (High) 176. In 2021, Low density lipoprotein: decreased (Low) cholesterol levels have decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The low-density lipoprotein Cholesterol was at 176 initially and the last test done 10 days after the vaccine showed significant decrease in cholesterol levels. The patient reported that there were blood tests and medical records to prove the correlation.  No treatment medication were provided.   This case was linked to MOD-2022-564739, MOD-2022-564749, MOD-2022-564750 (Patient Link).