chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Painful respiration, Tinnitus
Clinical narrative: Since 8/2/21, been dealing daily with extreme fatigue, lightheadedness, and dizziness. Every night hard time falling asleep and staying sleep, sleep is very scattered and never very long. Most days nausea and stomach pains. Ringing in the ears on some days. Today 8/16/21, new symptoms added: constant chest pain, pain taking a deep breath, and unable to complete a full deep breath. Have not sought medical attention yet, was given the info and link to come here and report my symptoms after completing daily check in today on website
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Lip swelling, Pyrexia, Swelling face
Clinical narrative: Around 9pm on August 14, 2021, I started to run a fever and felt a heaviness in my chest. I assumed these were just a sign of the vaccine kicking in. I went to bed to try and sleep it off around 11pm. When I awoke the next morning (August 15th) around 8 am, I saw that my face and lips were swollen and my chest was still heavy feeling. I placed a call to my healthcare provider on their emergency line to let her know what was going on. It was recommend that I take a steroid and  Benadryl or antihistamine to alleviate the symptoms. I was told to go to ER if symptoms got worse or to follow up in the office on Monday if it wasn't emergent. I took a dose of Dexamethasone around 9:45am. I then followed that around 11 am with a Zyrtec. I took Benadryl around 10pm on August 15th. By the time I awoke on Monday, August 16th, my symptoms had subsided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: On August 15, 2021, the patient noticed a red area of skin around the site of injection. She had no itching or pain. On examination from the pharmacist on August 16th, the area looked slightly inflamed and warm to the touch. The pharmacist traced the red area with a marker so the patient could evaluate whether the area was growing or shrinking. The pharmacist recommended OTC options such as ibuprofen, benadryl cream, or hydrocortisone cream.  The patient also had a small bruise right at the site where the needle was inserted.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Back pain, Fatigue, Heart rate increased
Clinical narrative: The patient was nervous about getting her COVID-19 vaccination due to autoimmune/Lyme disease health issues. We went over her VAR form, allergies, health conditions, and verified her MD still wanted her to get the covid shot. She came in with her elderly mother. She was given her first dose of Moderna around 7pm. I advised her to stay 15-20 minutes after her vaccination seated to ensure her safety. I noticed she was holding her head in her hand after about 10 minutes. I went out to check on her. She said she felt really tired, weak, had red blotches on her skin, felt heart rate high, back aches or pain. I checked her blood pressure twice and it was 150/101 and 171/101.  I called 911 to have her evaluated. She chose to go to the ER via ambulance due to pre-existing health conditions and felt this would be best. I felt so as well. It did seem the EMT and fire department didn't want to take her. I told them about her autoimmune issues and asked if they felt it was wise for her to go get monitored as I know she was very worried about an inflammatory response due to the Lyme/autoimmune disease health conditions.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: The patient was nervous about getting her COVID-19 vaccination due to autoimmune/Lyme disease health issues. We went over her VAR form, allergies, health conditions, and verified her MD still wanted her to get the covid shot. She came in with her elderly mother. She was given her first dose of Moderna around 7pm. I advised her to stay 15-20 minutes after her vaccination seated to ensure her safety. I noticed she was holding her head in her hand after about 10 minutes. I went out to check on her. She said she felt really tired, weak, had red blotches on her skin, felt heart rate high, back aches or pain. I checked her blood pressure twice and it was 150/101 and 171/101.  I called 911 to have her evaluated. She chose to go to the ER via ambulance due to pre-existing health conditions and felt this would be best. I felt so as well. It did seem the EMT and fire department didn't want to take her. I told them about her autoimmune issues and asked if they felt it was wise for her to go get monitored as I know she was very worried about an inflammatory response due to the Lyme/autoimmune disease health conditions.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Coccydynia, Dyschezia, Gait disturbance, Sitting disability, Spinal X-ray
Clinical narrative: Severe coccyx pain. Could not sit, and could barely walk. Having bowel movements also hurt for three days. I was given a medrol dose pack & received an x-ray which was negative. I am not sure if this was related to the
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Oedema, Ultrasound scan normal
Clinical narrative: I have pitted edema present only in my left foot. With the P.E., I have periods of discomfort. When I wake in the morning, the P.E. is mild. As the day progresses, it is more prevalent. This has been ongoing for almost 2 months diagnosis not yet defined as of this date
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Cerebrovascular accident, Computerised tomogram head abnormal, Computerised tomogram neck, Dizziness
Clinical narrative: vertigo dizziness new dx of emboli causing infarcts in the brain (CVA) started within 2 days of vaccine
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Embolism, Vertigo
Clinical narrative: vertigo dizziness new dx of emboli causing infarcts in the brain (CVA) started within 2 days of vaccine
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic cerebral infarction
Clinical narrative: 3/10/2021 Right frontal lobe ischemic infarct
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: pt had 15 min observation period, pt stated left sinus (cheek) areas was numb. No tongue tingling, or throat irritation Patient proceeded to do minor shopping and came back to ask about it but stated it as not progressing. He waited a few more minutes and his symptoms did not progress. I Informed him it "could" be a minor allergic reaction occurring or a effect of medication. I gave him 50 mg of Diphenhydramine orally and pt said he was going straight home. He live within 5 miles of sore. Pt was advised if any new symptoms occurred, especially trouble breathing or throat Irritation, to go to the doctor. I spoke to his wife w/n an hr, stated he said he felt okay.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Swelling face
Clinical narrative: Right side facial swelling Right side facial drooping
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: He died after experiencing a heart attack
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Amplified musculoskeletal pain syndrome, Arthralgia, Autonomic nervous system imbalance, Cardiac stress test abnormal
Clinical narrative: -HA / Nausea / dizziness reported the day of vaccine, followed by chest tightness and shortness breath by second week. Trial of albuterol/xopenex without improvement.  -3rd week - pt developed fatigue, chest pain and joint pains. Referred to Pulm/Rheum - postural tachycardia noted at Rheum visit Pt diagnosed with dysautonomia/AMPS by Rheum 5/6/2021 5/19/2021 ER visit for throat itching/trouble swallowing, abdominal pain + nausea  -Epipen, IVF, antihistamine/steroids given 5/20/2021 - symptoms returned. Epipen given at home. ER treatment - IVF /IV steroids and Atrovent. D/C'd home on PO prednisone, Zyrtec + Pepcid.  6/8/2021 - started on omeprazole by GI for IBS-D 6/3/2021 - seen by Cardiology for chest pain /syncopal symptoms.  - Echo: Sinus bradycardia, LV function @ lower limit of normal, no effusion -ECG: Sinus bradycardia with short PR interval with pre-excitation -Abnormal stress test with EKG changes with exercise (ST segment depression in Leads II, III, aVF and V3-V6, resolves in recovery) 6/3/2021 - starts PT for POTS/AMPS 7/6/2021 Cardiac MRI  - mild enlargement of LV w/normal systolic function - nl RV/function - no sign of MI, myocarditis or cardiomyopathy.  7/13/2021 - palpitations/POTS. Started on metoprolol XL 12.5 mg.  As of 7/29/2021, pt improving. Decrease in palpitations and increase of activity. Still fatigued. Tolerating PT and metoprolol.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Chest pain, Dizziness, Dysphagia
Clinical narrative: -HA / Nausea / dizziness reported the day of vaccine, followed by chest tightness and shortness breath by second week. Trial of albuterol/xopenex without improvement.  -3rd week - pt developed fatigue, chest pain and joint pains. Referred to Pulm/Rheum - postural tachycardia noted at Rheum visit Pt diagnosed with dysautonomia/AMPS by Rheum 5/6/2021 5/19/2021 ER visit for throat itching/trouble swallowing, abdominal pain + nausea  -Epipen, IVF, antihistamine/steroids given 5/20/2021 - symptoms returned. Epipen given at home. ER treatment - IVF /IV steroids and Atrovent. D/C'd home on PO prednisone, Zyrtec + Pepcid.  6/8/2021 - started on omeprazole by GI for IBS-D 6/3/2021 - seen by Cardiology for chest pain /syncopal symptoms.  - Echo: Sinus bradycardia, LV function @ lower limit of normal, no effusion -ECG: Sinus bradycardia with short PR interval with pre-excitation -Abnormal stress test with EKG changes with exercise (ST segment depression in Leads II, III, aVF and V3-V6, resolves in recovery) 6/3/2021 - starts PT for POTS/AMPS 7/6/2021 Cardiac MRI  - mild enlargement of LV w/normal systolic function - nl RV/function - no sign of MI, myocarditis or cardiomyopathy.  7/13/2021 - palpitations/POTS. Started on metoprolol XL 12.5 mg.  As of 7/29/2021, pt improving. Decrease in palpitations and increase of activity. Still fatigued. Tolerating PT and metoprolol.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Electrocardiogram PR shortened, Electrocardiogram ST segment depression, Electrocardiogram abnormal
Clinical narrative: -HA / Nausea / dizziness reported the day of vaccine, followed by chest tightness and shortness breath by second week. Trial of albuterol/xopenex without improvement.  -3rd week - pt developed fatigue, chest pain and joint pains. Referred to Pulm/Rheum - postural tachycardia noted at Rheum visit Pt diagnosed with dysautonomia/AMPS by Rheum 5/6/2021 5/19/2021 ER visit for throat itching/trouble swallowing, abdominal pain + nausea  -Epipen, IVF, antihistamine/steroids given 5/20/2021 - symptoms returned. Epipen given at home. ER treatment - IVF /IV steroids and Atrovent. D/C'd home on PO prednisone, Zyrtec + Pepcid.  6/8/2021 - started on omeprazole by GI for IBS-D 6/3/2021 - seen by Cardiology for chest pain /syncopal symptoms.  - Echo: Sinus bradycardia, LV function @ lower limit of normal, no effusion -ECG: Sinus bradycardia with short PR interval with pre-excitation -Abnormal stress test with EKG changes with exercise (ST segment depression in Leads II, III, aVF and V3-V6, resolves in recovery) 6/3/2021 - starts PT for POTS/AMPS 7/6/2021 Cardiac MRI  - mild enlargement of LV w/normal systolic function - nl RV/function - no sign of MI, myocarditis or cardiomyopathy.  7/13/2021 - palpitations/POTS. Started on metoprolol XL 12.5 mg.  As of 7/29/2021, pt improving. Decrease in palpitations and increase of activity. Still fatigued. Tolerating PT and metoprolol.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count normal, Headache, Irritable bowel syndrome, Left ventricular dysfunction
Clinical narrative: -HA / Nausea / dizziness reported the day of vaccine, followed by chest tightness and shortness breath by second week. Trial of albuterol/xopenex without improvement.  -3rd week - pt developed fatigue, chest pain and joint pains. Referred to Pulm/Rheum - postural tachycardia noted at Rheum visit Pt diagnosed with dysautonomia/AMPS by Rheum 5/6/2021 5/19/2021 ER visit for throat itching/trouble swallowing, abdominal pain + nausea  -Epipen, IVF, antihistamine/steroids given 5/20/2021 - symptoms returned. Epipen given at home. ER treatment - IVF /IV steroids and Atrovent. D/C'd home on PO prednisone, Zyrtec + Pepcid.  6/8/2021 - started on omeprazole by GI for IBS-D 6/3/2021 - seen by Cardiology for chest pain /syncopal symptoms.  - Echo: Sinus bradycardia, LV function @ lower limit of normal, no effusion -ECG: Sinus bradycardia with short PR interval with pre-excitation -Abnormal stress test with EKG changes with exercise (ST segment depression in Leads II, III, aVF and V3-V6, resolves in recovery) 6/3/2021 - starts PT for POTS/AMPS 7/6/2021 Cardiac MRI  - mild enlargement of LV w/normal systolic function - nl RV/function - no sign of MI, myocarditis or cardiomyopathy.  7/13/2021 - palpitations/POTS. Started on metoprolol XL 12.5 mg.  As of 7/29/2021, pt improving. Decrease in palpitations and increase of activity. Still fatigued. Tolerating PT and metoprolol.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Metabolic function test normal, Nausea, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: -HA / Nausea / dizziness reported the day of vaccine, followed by chest tightness and shortness breath by second week. Trial of albuterol/xopenex without improvement.  -3rd week - pt developed fatigue, chest pain and joint pains. Referred to Pulm/Rheum - postural tachycardia noted at Rheum visit Pt diagnosed with dysautonomia/AMPS by Rheum 5/6/2021 5/19/2021 ER visit for throat itching/trouble swallowing, abdominal pain + nausea  -Epipen, IVF, antihistamine/steroids given 5/20/2021 - symptoms returned. Epipen given at home. ER treatment - IVF /IV steroids and Atrovent. D/C'd home on PO prednisone, Zyrtec + Pepcid.  6/8/2021 - started on omeprazole by GI for IBS-D 6/3/2021 - seen by Cardiology for chest pain /syncopal symptoms.  - Echo: Sinus bradycardia, LV function @ lower limit of normal, no effusion -ECG: Sinus bradycardia with short PR interval with pre-excitation -Abnormal stress test with EKG changes with exercise (ST segment depression in Leads II, III, aVF and V3-V6, resolves in recovery) 6/3/2021 - starts PT for POTS/AMPS 7/6/2021 Cardiac MRI  - mild enlargement of LV w/normal systolic function - nl RV/function - no sign of MI, myocarditis or cardiomyopathy.  7/13/2021 - palpitations/POTS. Started on metoprolol XL 12.5 mg.  As of 7/29/2021, pt improving. Decrease in palpitations and increase of activity. Still fatigued. Tolerating PT and metoprolol.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary function test normal, Red blood cell sedimentation rate normal, SARS-CoV-2 test negative, Sinus bradycardia, Syncope
Clinical narrative: -HA / Nausea / dizziness reported the day of vaccine, followed by chest tightness and shortness breath by second week. Trial of albuterol/xopenex without improvement.  -3rd week - pt developed fatigue, chest pain and joint pains. Referred to Pulm/Rheum - postural tachycardia noted at Rheum visit Pt diagnosed with dysautonomia/AMPS by Rheum 5/6/2021 5/19/2021 ER visit for throat itching/trouble swallowing, abdominal pain + nausea  -Epipen, IVF, antihistamine/steroids given 5/20/2021 - symptoms returned. Epipen given at home. ER treatment - IVF /IV steroids and Atrovent. D/C'd home on PO prednisone, Zyrtec + Pepcid.  6/8/2021 - started on omeprazole by GI for IBS-D 6/3/2021 - seen by Cardiology for chest pain /syncopal symptoms.  - Echo: Sinus bradycardia, LV function @ lower limit of normal, no effusion -ECG: Sinus bradycardia with short PR interval with pre-excitation -Abnormal stress test with EKG changes with exercise (ST segment depression in Leads II, III, aVF and V3-V6, resolves in recovery) 6/3/2021 - starts PT for POTS/AMPS 7/6/2021 Cardiac MRI  - mild enlargement of LV w/normal systolic function - nl RV/function - no sign of MI, myocarditis or cardiomyopathy.  7/13/2021 - palpitations/POTS. Started on metoprolol XL 12.5 mg.  As of 7/29/2021, pt improving. Decrease in palpitations and increase of activity. Still fatigued. Tolerating PT and metoprolol.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Thyroid function test normal
Clinical narrative: -HA / Nausea / dizziness reported the day of vaccine, followed by chest tightness and shortness breath by second week. Trial of albuterol/xopenex without improvement.  -3rd week - pt developed fatigue, chest pain and joint pains. Referred to Pulm/Rheum - postural tachycardia noted at Rheum visit Pt diagnosed with dysautonomia/AMPS by Rheum 5/6/2021 5/19/2021 ER visit for throat itching/trouble swallowing, abdominal pain + nausea  -Epipen, IVF, antihistamine/steroids given 5/20/2021 - symptoms returned. Epipen given at home. ER treatment - IVF /IV steroids and Atrovent. D/C'd home on PO prednisone, Zyrtec + Pepcid.  6/8/2021 - started on omeprazole by GI for IBS-D 6/3/2021 - seen by Cardiology for chest pain /syncopal symptoms.  - Echo: Sinus bradycardia, LV function @ lower limit of normal, no effusion -ECG: Sinus bradycardia with short PR interval with pre-excitation -Abnormal stress test with EKG changes with exercise (ST segment depression in Leads II, III, aVF and V3-V6, resolves in recovery) 6/3/2021 - starts PT for POTS/AMPS 7/6/2021 Cardiac MRI  - mild enlargement of LV w/normal systolic function - nl RV/function - no sign of MI, myocarditis or cardiomyopathy.  7/13/2021 - palpitations/POTS. Started on metoprolol XL 12.5 mg.  As of 7/29/2021, pt improving. Decrease in palpitations and increase of activity. Still fatigued. Tolerating PT and metoprolol.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: S/S COVID
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Staphylococcal infection
Clinical narrative: Patient reports redness and swelling at injection site that was diagnosed as a staph infection by ER provider. Treatment unknown. Called pharmacy on 8-16-21 to report
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Dyspnoea, Feeling hot, Rash
Clinical narrative: Pt  called 2 days after getting  vaccine  stated  temp was 100. F.  Rash , on arm & arm "on fire "  difficulty  breathing like as than altar  But pt states she does have asthma
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Inflammation, Joint range of motion decreased
Clinical narrative: Shoulder Inflamation - severe pain and reduced ROM treated with oral steroids , NSAIDS, resting/reduce use of injured arm and at home stretching
Age: 4.0
Sex: F
Vaccine: DTAP, DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received two doses of  Dtap on the same day. The patient didnot  have any adverse  event, treatment  or  outcome.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G decreased, COVID-19, Convalescent plasma transfusion, Dyspnoea, Immunoglobulin therapy
Clinical narrative: Date of Awareness:  8/13/21  73 y/o male who takes Pomalyst, dexamethasone and daratumumab for MM.  Pt was fully vaccinated against Covid-19 but presented to ER on 7/14/21-7/22/21 with SOB and was subsequently admitted for treatment of Covid-19.  Upon admission he was started on dexamethasone and Remdesivir.  He also received a dose of convalescent plasma.  His IGG level was found to be low, and after consultation with immunology he received two doses of IVIG and also treated with azithromycin and ceftriaxone for possible superimposed CAP.  Patient was eventually d/c'd home in stable condition but next cycle of chemo was delayed several weeks to allow patient to recover.  Patient will resume next cycle on 8/16/21
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Parent wanted to report loss of taste which occurred post COVID vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Acne cystic, Pain, Skin discolouration, Skin mass
Clinical narrative: I've never had a great deal of acne. Maybe a 1 or 2 pimples during my menstrual cycle, but since taking the vaccine I've had hurge clumps of cystic acne on my chin and jawbone, which is causing dark spots on my skin. It is extremely painful and shows no signs of disappearing. I purchased an acne skin care system so fight the acne but it seems not to be able to make a dent in my fight against the acne. These bumps are under the skin and are extremely painful. I just received my 2nd shot of Pfizer yesterday 8-14-2021. and I woke to a painful skin bump on my forehead. Im not sure to now
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain
Clinical narrative: REPORTER STATED THAT HE WAS TESTED FOR COVID 19 IN THE MONTH OF FEBRUARY, MARCH AND APRIL 2021 AND ALL THE THE RESULTS CAME BACK NEGATIVE.  HE FINALLY GOT THE JOHNSON AND JOHNSON VACCINE IN  APRIL 2021 AND SINCE THEN HE HAS BEEN EXPERIENCING HEADACHE THAT WILL NOT GO AWAY.  HE FURTHER STATED THAT HE FELT ALL BODY ACHE AND WAS VERY SICK AFTER TAKING THE VACCINE. REPORTER BELIEVES HIS HEADACHE IS FROM THE VACCINE.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: Received Pneumovax vaccine left arm 8/4/2021.Received at pharmacy. Severe pain and inability to move arm. Much worse than would be expected. Required 600mg Ibuprofen ever 3-4 hours around the clock 3 days. Unable to sleep due to severe pain. Today is 8/16/21 and I still have mod pain. I am a NICU nurse and have to be careful in picking up a 7lb infant due to pain and weakness of left arm.. I was only told I might have soreness 24hours. Do I need to see a doctor about this?
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malignant nipple neoplasm female, Nausea, Neoplasm malignant, Pain in extremity
Clinical narrative: patient indicated that they were dizzy, nauseous, pain in arm with lightheadedness, high fever for more than 2 days after initiation of the 1st covid vaccine. patient wanted to report that afinitor may be contributing. advised to speak to md and no other information provided. indication: malignant neoplasm of nipple and areola, right female breast
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: patient indicated that they were dizzy, nauseous, pain in arm with lightheadedness, high fever for more than 2 days after initiation of the 1st covid vaccine. patient wanted to report that afinitor may be contributing. advised to speak to md and no other information provided. indication: malignant neoplasm of nipple and areola, right female breast
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Men CYW liquid conjugate portion only of Menveo vaccine and the vaccine was not reconstituted with the lyophilized Men A portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional did not have patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case was 1 of 8 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169160:Same reporter US-GLAXOSMITHKLINE-US2021AMR170397:Same reporter US-GLAXOSMITHKLINE-US2021AMR170398:Same reporter US-GLAXOSMITHKLINE-US2021AMR170403:Same reporter US-GLAXOSMITHKLINE-US2021AMR170401:Same reporter US-GLAXOSMITHKLINE-US2021AMR170400:Same reporter US-GLAXOSMITHKLINE-US2021AMR170402:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Men CYW liquid conjugate portion only of Menveo vaccine and the vaccine was not reconstituted with the lyophilized Men A portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional did not have patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case was 1 of 8 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169160:Same reporter US-GLAXOSMITHKLINE-US2021AMR170397:Same reporter US-GLAXOSMITHKLINE-US2021AMR170403:Same reporter US-GLAXOSMITHKLINE-US2021AMR170401:Same reporter US-GLAXOSMITHKLINE-US2021AMR170402:Same reporter US-GLAXOSMITHKLINE-US2021AMR170399:Same reporter US-GLAXOSMITHKLINE-US2021AMR170400:Same reporter
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Epistaxis, Facial discomfort, Facial pain
Clinical narrative: Initially started with fever low-grade fever (99s) then by the 24 hour mark had 104+ with chills and sweats. I was febrile for 2-3 days. Parotid and submandibular glands were swollen and tender on the left side of my face and my left ear hurt. My left cheek. . . over sinus was sore and is still mildly tender when I apply blush.   It hurt to open my mouth.  My left eye was itchy.   I had  thin secretion from my nose.   The runny nose lasted 2-3 weeks and stunk like dead animal if I bent down at which point I noticed the secretion was mildly blood tinged.     I was febrile for 2-3 days.     I stayed home and self treated with tylenol.  Missed two days of work.   Called to let employee health know but was not given the impression they were taking any data on reactions.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pyrexia, Rhinorrhoea, Toothache
Clinical narrative: Initially started with fever low-grade fever (99s) then by the 24 hour mark had 104+ with chills and sweats. I was febrile for 2-3 days. Parotid and submandibular glands were swollen and tender on the left side of my face and my left ear hurt. My left cheek. . . over sinus was sore and is still mildly tender when I apply blush.   It hurt to open my mouth.  My left eye was itchy.   I had  thin secretion from my nose.   The runny nose lasted 2-3 weeks and stunk like dead animal if I bent down at which point I noticed the secretion was mildly blood tinged.     I was febrile for 2-3 days.     I stayed home and self treated with tylenol.  Missed two days of work.   Called to let employee health know but was not given the impression they were taking any data on reactions.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Ear pain, Epistaxis, Eye pruritus, Facial pain
Clinical narrative: Initially started with fever low-grade fever (99s) then by the 24 hour mark had 104+ with chills and sweats. I was febrile for 2-3 days. Parotid and submandibular glands were swollen and tender on the left side of my face and my left ear hurt. My left cheek. . . over sinus was sore and is still mildly tender when I apply blush.   It hurt to open my mouth.  My left eye was itchy.   I had  thin secretion from my nose.   The runny nose lasted 2-3 weeks and stunk like dead animal if I bent down at which point I noticed the secretion was mildly blood tinged.     I was febrile for 2-3 days.     I stayed home and self treated with tylenol.  Missed two days of work.   Called to let employee health know but was not given the impression they were taking any data on reactions.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Impaired work ability, Jaw disorder, Lymphadenopathy, Parosmia
Clinical narrative: Initially started with fever low-grade fever (99s) then by the 24 hour mark had 104+ with chills and sweats. I was febrile for 2-3 days. Parotid and submandibular glands were swollen and tender on the left side of my face and my left ear hurt. My left cheek. . . over sinus was sore and is still mildly tender when I apply blush.   It hurt to open my mouth.  My left eye was itchy.   I had  thin secretion from my nose.   The runny nose lasted 2-3 weeks and stunk like dead animal if I bent down at which point I noticed the secretion was mildly blood tinged.     I was febrile for 2-3 days.     I stayed home and self treated with tylenol.  Missed two days of work.   Called to let employee health know but was not given the impression they were taking any data on reactions.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rhinorrhoea, Secretion discharge, Tenderness
Clinical narrative: Initially started with fever low-grade fever (99s) then by the 24 hour mark had 104+ with chills and sweats. I was febrile for 2-3 days. Parotid and submandibular glands were swollen and tender on the left side of my face and my left ear hurt. My left cheek. . . over sinus was sore and is still mildly tender when I apply blush.   It hurt to open my mouth.  My left eye was itchy.   I had  thin secretion from my nose.   The runny nose lasted 2-3 weeks and stunk like dead animal if I bent down at which point I noticed the secretion was mildly blood tinged.     I was febrile for 2-3 days.     I stayed home and self treated with tylenol.  Missed two days of work.   Called to let employee health know but was not given the impression they were taking any data on reactions.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Headache, Muscular weakness, Neck pain
Clinical narrative: Stopped eating, severe neck spasms and pain, loss of coordination and balance.  Eventually went on hospice on June 2, and died July 16.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Coordination abnormal, Death, Hypophagia, Muscle spasms
Clinical narrative: Stopped eating, severe neck spasms and pain, loss of coordination and balance.  Eventually went on hospice on June 2, and died July 16.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain
Clinical narrative: Stopped eating, severe neck spasms and pain, loss of coordination and balance.  Eventually went on hospice on June 2, and died July 16.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Antinuclear antibody, Antiphospholipid antibodies, Antithrombin III, Beta-2 glycoprotein antibody
Clinical narrative: Coagulopathy ED visit, hospital stay, prescription medication, surgical procedure Notes from 5/14/21 - He seems to have provoked clot, provoking events being the Johnson & Johnson COVID-19 vaccine and surgical procedure. Plan for AC for 6 months given high clot burden d dimer today.   Previous notes: He had J and J vaccine on Sat 3/27 During his follow up clinic on 3/29/21, he reported abdominal discomfort and low grade fever, which persists with abdominal and back pain and low grade fever and presented to ED on 3/31/21 and admitted to Hospital with SMV, PV and Splenic Vein thrombosis, wed no significant hematologic disease. He underwent CT A/P with IV contrast, which revealed "acute thrombosis of the portal, splenic, and superior mesenteric veins with resultant small bowel thickening/edema related to venous outflow obstruction."   The patient improved and was discharged on 4/17/21. Subsequently, the patient did well, then recent US showed slowing down of velocity of TIPS, then received SMV venoplasty and TIPS revision on 6/10/21. The patient has recently changed from Eliquis to Fondaparinux since 6/2/21 after the report. Patient has since changed to warfarin management.  No leg swelling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood fibrinogen, Cardiolipin antibody, Coagulation factor V level normal, Computerised tomogram abdomen, Computerised tomogram abnormal
Clinical narrative: Coagulopathy ED visit, hospital stay, prescription medication, surgical procedure Notes from 5/14/21 - He seems to have provoked clot, provoking events being the Johnson & Johnson COVID-19 vaccine and surgical procedure. Plan for AC for 6 months given high clot burden d dimer today.   Previous notes: He had J and J vaccine on Sat 3/27 During his follow up clinic on 3/29/21, he reported abdominal discomfort and low grade fever, which persists with abdominal and back pain and low grade fever and presented to ED on 3/31/21 and admitted to Hospital with SMV, PV and Splenic Vein thrombosis, wed no significant hematologic disease. He underwent CT A/P with IV contrast, which revealed "acute thrombosis of the portal, splenic, and superior mesenteric veins with resultant small bowel thickening/edema related to venous outflow obstruction."   The patient improved and was discharged on 4/17/21. Subsequently, the patient did well, then recent US showed slowing down of velocity of TIPS, then received SMV venoplasty and TIPS revision on 6/10/21. The patient has recently changed from Eliquis to Fondaparinux since 6/2/21 after the report. Patient has since changed to warfarin management.  No leg swelling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Explorative laparotomy, Gene mutation identification test negative, Haptoglobin, Heparin-induced thrombocytopenia test
Clinical narrative: Coagulopathy ED visit, hospital stay, prescription medication, surgical procedure Notes from 5/14/21 - He seems to have provoked clot, provoking events being the Johnson & Johnson COVID-19 vaccine and surgical procedure. Plan for AC for 6 months given high clot burden d dimer today.   Previous notes: He had J and J vaccine on Sat 3/27 During his follow up clinic on 3/29/21, he reported abdominal discomfort and low grade fever, which persists with abdominal and back pain and low grade fever and presented to ED on 3/31/21 and admitted to Hospital with SMV, PV and Splenic Vein thrombosis, wed no significant hematologic disease. He underwent CT A/P with IV contrast, which revealed "acute thrombosis of the portal, splenic, and superior mesenteric veins with resultant small bowel thickening/edema related to venous outflow obstruction."   The patient improved and was discharged on 4/17/21. Subsequently, the patient did well, then recent US showed slowing down of velocity of TIPS, then received SMV venoplasty and TIPS revision on 6/10/21. The patient has recently changed from Eliquis to Fondaparinux since 6/2/21 after the report. Patient has since changed to warfarin management.  No leg swelling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mechanical ventilation, Mesenteric vein thrombosis, Pneumatosis intestinalis, Portal shunt procedure, Portal vein thrombosis
Clinical narrative: Coagulopathy ED visit, hospital stay, prescription medication, surgical procedure Notes from 5/14/21 - He seems to have provoked clot, provoking events being the Johnson & Johnson COVID-19 vaccine and surgical procedure. Plan for AC for 6 months given high clot burden d dimer today.   Previous notes: He had J and J vaccine on Sat 3/27 During his follow up clinic on 3/29/21, he reported abdominal discomfort and low grade fever, which persists with abdominal and back pain and low grade fever and presented to ED on 3/31/21 and admitted to Hospital with SMV, PV and Splenic Vein thrombosis, wed no significant hematologic disease. He underwent CT A/P with IV contrast, which revealed "acute thrombosis of the portal, splenic, and superior mesenteric veins with resultant small bowel thickening/edema related to venous outflow obstruction."   The patient improved and was discharged on 4/17/21. Subsequently, the patient did well, then recent US showed slowing down of velocity of TIPS, then received SMV venoplasty and TIPS revision on 6/10/21. The patient has recently changed from Eliquis to Fondaparinux since 6/2/21 after the report. Patient has since changed to warfarin management.  No leg swelling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Protein C, Protein S, Splenic vein thrombosis
Clinical narrative: Coagulopathy ED visit, hospital stay, prescription medication, surgical procedure Notes from 5/14/21 - He seems to have provoked clot, provoking events being the Johnson & Johnson COVID-19 vaccine and surgical procedure. Plan for AC for 6 months given high clot burden d dimer today.   Previous notes: He had J and J vaccine on Sat 3/27 During his follow up clinic on 3/29/21, he reported abdominal discomfort and low grade fever, which persists with abdominal and back pain and low grade fever and presented to ED on 3/31/21 and admitted to Hospital with SMV, PV and Splenic Vein thrombosis, wed no significant hematologic disease. He underwent CT A/P with IV contrast, which revealed "acute thrombosis of the portal, splenic, and superior mesenteric veins with resultant small bowel thickening/edema related to venous outflow obstruction."   The patient improved and was discharged on 4/17/21. Subsequently, the patient did well, then recent US showed slowing down of velocity of TIPS, then received SMV venoplasty and TIPS revision on 6/10/21. The patient has recently changed from Eliquis to Fondaparinux since 6/2/21 after the report. Patient has since changed to warfarin management.  No leg swelling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Angioplasty, Anticoagulant therapy, Back pain
Clinical narrative: Coagulopathy ED visit, hospital stay, prescription medication, surgical procedure Notes from 5/14/21 - He seems to have provoked clot, provoking events being the Johnson & Johnson COVID-19 vaccine and surgical procedure. Plan for AC for 6 months given high clot burden d dimer today.   Previous notes: He had J and J vaccine on Sat 3/27 During his follow up clinic on 3/29/21, he reported abdominal discomfort and low grade fever, which persists with abdominal and back pain and low grade fever and presented to ED on 3/31/21 and admitted to Hospital with SMV, PV and Splenic Vein thrombosis, wed no significant hematologic disease. He underwent CT A/P with IV contrast, which revealed "acute thrombosis of the portal, splenic, and superior mesenteric veins with resultant small bowel thickening/edema related to venous outflow obstruction."   The patient improved and was discharged on 4/17/21. Subsequently, the patient did well, then recent US showed slowing down of velocity of TIPS, then received SMV venoplasty and TIPS revision on 6/10/21. The patient has recently changed from Eliquis to Fondaparinux since 6/2/21 after the report. Patient has since changed to warfarin management.  No leg swelling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coagulopathy, Computerised tomogram abdomen, Fibrin D dimer increased, Gastrointestinal wall thickening, Intestinal angioedema
Clinical narrative: Coagulopathy ED visit, hospital stay, prescription medication, surgical procedure Notes from 5/14/21 - He seems to have provoked clot, provoking events being the Johnson & Johnson COVID-19 vaccine and surgical procedure. Plan for AC for 6 months given high clot burden d dimer today.   Previous notes: He had J and J vaccine on Sat 3/27 During his follow up clinic on 3/29/21, he reported abdominal discomfort and low grade fever, which persists with abdominal and back pain and low grade fever and presented to ED on 3/31/21 and admitted to Hospital with SMV, PV and Splenic Vein thrombosis, wed no significant hematologic disease. He underwent CT A/P with IV contrast, which revealed "acute thrombosis of the portal, splenic, and superior mesenteric veins with resultant small bowel thickening/edema related to venous outflow obstruction."   The patient improved and was discharged on 4/17/21. Subsequently, the patient did well, then recent US showed slowing down of velocity of TIPS, then received SMV venoplasty and TIPS revision on 6/10/21. The patient has recently changed from Eliquis to Fondaparinux since 6/2/21 after the report. Patient has since changed to warfarin management.  No leg swelling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mesenteric vein thrombosis, Portal shunt procedure, Portal vein thrombosis, Pyrexia, Scan with contrast abnormal
Clinical narrative: Coagulopathy ED visit, hospital stay, prescription medication, surgical procedure Notes from 5/14/21 - He seems to have provoked clot, provoking events being the Johnson & Johnson COVID-19 vaccine and surgical procedure. Plan for AC for 6 months given high clot burden d dimer today.   Previous notes: He had J and J vaccine on Sat 3/27 During his follow up clinic on 3/29/21, he reported abdominal discomfort and low grade fever, which persists with abdominal and back pain and low grade fever and presented to ED on 3/31/21 and admitted to Hospital with SMV, PV and Splenic Vein thrombosis, wed no significant hematologic disease. He underwent CT A/P with IV contrast, which revealed "acute thrombosis of the portal, splenic, and superior mesenteric veins with resultant small bowel thickening/edema related to venous outflow obstruction."   The patient improved and was discharged on 4/17/21. Subsequently, the patient did well, then recent US showed slowing down of velocity of TIPS, then received SMV venoplasty and TIPS revision on 6/10/21. The patient has recently changed from Eliquis to Fondaparinux since 6/2/21 after the report. Patient has since changed to warfarin management.  No leg swelling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Splenic vein thrombosis, Surgery, Thrombosis, Ultrasound scan abnormal, Venous occlusion
Clinical narrative: Coagulopathy ED visit, hospital stay, prescription medication, surgical procedure Notes from 5/14/21 - He seems to have provoked clot, provoking events being the Johnson & Johnson COVID-19 vaccine and surgical procedure. Plan for AC for 6 months given high clot burden d dimer today.   Previous notes: He had J and J vaccine on Sat 3/27 During his follow up clinic on 3/29/21, he reported abdominal discomfort and low grade fever, which persists with abdominal and back pain and low grade fever and presented to ED on 3/31/21 and admitted to Hospital with SMV, PV and Splenic Vein thrombosis, wed no significant hematologic disease. He underwent CT A/P with IV contrast, which revealed "acute thrombosis of the portal, splenic, and superior mesenteric veins with resultant small bowel thickening/edema related to venous outflow obstruction."   The patient improved and was discharged on 4/17/21. Subsequently, the patient did well, then recent US showed slowing down of velocity of TIPS, then received SMV venoplasty and TIPS revision on 6/10/21. The patient has recently changed from Eliquis to Fondaparinux since 6/2/21 after the report. Patient has since changed to warfarin management.  No leg swelling.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Foaming at mouth, Lip haemorrhage, Loss of consciousness, Seizure like phenomena
Clinical narrative: Vaccine was administered around 12:30PM Wednesday 5/12/21. At approximately 12:34PM seizure occurred. Seizure caused fractured spine. Fractured spine resulted in loss of work/mobility. Second seizure occurred 1 month later, resulting in more back pain/fracture and broken shoulder. Had no prior neurology issues or family history with seizures. Saw a Neurologist and was prescribed Lamotrigine.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Computerised tomogram, Electroencephalogram, Impaired work ability, Magnetic resonance imaging
Clinical narrative: Vaccine was administered around 12:30PM Wednesday 5/12/21. At approximately 12:34PM seizure occurred. Seizure caused fractured spine. Fractured spine resulted in loss of work/mobility. Second seizure occurred 1 month later, resulting in more back pain/fracture and broken shoulder. Had no prior neurology issues or family history with seizures. Saw a Neurologist and was prescribed Lamotrigine.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Seizure, Spinal fracture, Upper limb fracture, X-ray
Clinical narrative: Vaccine was administered around 12:30PM Wednesday 5/12/21. At approximately 12:34PM seizure occurred. Seizure caused fractured spine. Fractured spine resulted in loss of work/mobility. Second seizure occurred 1 month later, resulting in more back pain/fracture and broken shoulder. Had no prior neurology issues or family history with seizures. Saw a Neurologist and was prescribed Lamotrigine.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Oral mucosal blistering, Tongue blistering
Clinical narrative: developed mucositis, bullae like blisters on may 24th .  severe oral ulcerations. Later had recurrence with the dermatologist doing biopsy at end of July 2021 pathology done at facility on july 21, 20201 Diagnosis: Epidermolysis Bullosa Acquisita
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Blister, Oral mucosal blistering, Pain of skin, Pruritus
Clinical narrative: developed mucositis, bullae like blisters on may 24th .  severe oral ulcerations. Later had recurrence with the dermatologist doing biopsy at end of July 2021 pathology done at facility on july 21, 20201 Diagnosis: Epidermolysis Bullosa Acquisita
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Skin burning sensation, Sleep disorder
Clinical narrative: developed mucositis, bullae like blisters on may 24th .  severe oral ulcerations. Later had recurrence with the dermatologist doing biopsy at end of July 2021 pathology done at facility on july 21, 20201 Diagnosis: Epidermolysis Bullosa Acquisita
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acquired epidermolysis bullosa, Biopsy, Blister, Mouth ulceration, Mucosal inflammation
Clinical narrative: developed mucositis, bullae like blisters on may 24th .  severe oral ulcerations. Later had recurrence with the dermatologist doing biopsy at end of July 2021 pathology done at facility on july 21, 20201 Diagnosis: Epidermolysis Bullosa Acquisita
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Healthcare provider reported the following details of event to our safety reporting system: "Patient came for consultation on 7/7/2021 for tinnitus that started same day as first dose of moderna vaccine. There was no other cause that is detected and it is felt that the sudden onset of the tinnitus could be temporally related to the vaccine." Other notes: vaccine was administered at outside facility and unable to obtain additional vaccine details. Unclear if patient and/or MD may have also reported  this adverse event to VAERS.