chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myasthenia Gravis; Death; Hallucinations; confusion; shortness of breath; dizziness; stroke like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), MYASTHENIA GRAVIS (Myasthenia Gravis) and HALLUCINATION (Hallucinations) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (20 years ago).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia Gravis) (seriousness criteria death, hospitalization prolonged and medically significant), HALLUCINATION (Hallucinations) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms). The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HALLUCINATION (Hallucinations), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms) outcome was unknown.            Patient started experiencing side effects 2 weeks after taking the vaccine. He was taken to the hospital for stroke like symptoms but it was ruled out by X-ray. He went to the hospital as symptoms persisted & got admitted on 13March2021. He died 24 hour later after being diagnosed with Myasthenia Gravis and thymus removal refusal. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Difficulty breathing / Still currently feeling shortness of breath; Chest Pain; Feeling unwell for several days; Arm Pain; Injection site redness- left arm; After the shot vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing / Still currently feeling shortness of breath), CHEST PAIN (Chest Pain), MALAISE (Feeling unwell for several days), PAIN IN EXTREMITY (Arm Pain) and VACCINATION SITE ERYTHEMA (Injection site redness- left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced DYSPNOEA (Difficulty breathing / Still currently feeling shortness of breath), CHEST PAIN (Chest Pain), MALAISE (Feeling unwell for several days), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Injection site redness- left arm) and VOMITING (After the shot vomiting). On 13-Nov-2021, DYSPNOEA (Difficulty breathing / Still currently feeling shortness of breath), CHEST PAIN (Chest Pain), MALAISE (Feeling unwell for several days), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Injection site redness- left arm) and VOMITING (After the shot vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, Electrocardiogram: normal (normal) Normal. On an unknown date, Heart rate increased: increased (High) fast heart beat.         No relevant concomitant medications reported.  No treatment information was provided.  Patient had no history of COVID-19 and  Myocarditis/pericarditis.   Reporter did not allow further contact
The pt woke at 1:00 am with a fever of 102 and itchy generalized rash, which was small and raised. Given Tylenol for fever. Hands and feet swollen. Spoke to MD and instructed to give Benadryl for rash. At 4:30 pm hands and feet swollen and still has fever and rash.
pt devel 5 bald spots on scalp-various sizes;1 day p/2nd vax skin blotchy (not hives);taken to MD next day w/fever up to 103 tx for ear infect-had malaise & h/a on ATB;to MD dx autoimmune rxn;hypersensitive rxn triggered autoimmune response
Discharge Provider: MD Primary Care Provider at Discharge: MD     Admission Date: 3/21/2023 Discharge Date: Condition on discharge:  Patient is a 91 y.o. male with past medical history significant for CAD, DM type 2, CKD stage 3, and Waldenstrom  macroglbulinemia who presented to ED on 3/211/23 for weakness.  His wife was recently diagnosed with COVID-19, patient also developed symptoms with malaise, poor appetite, cough and diarrhea.  He became progressively weak.  He was too weak to get up from his chair therefore he presented to the emergency department.  He also reported dizziness.  In the emergency department he was found to be hemodynamically stable and not hypoxic.  He did test positive for COVID-19 and chest x-ray is consistent with COVID-19 pneumonia.  He was unable ambulate therefore he was admitted to the hospital to the general medicine service.   He was treated with remdesivir, dexamethasone initially was started but then discontinued after the patient was not requiring oxygen.   Does have a history of type 2 diabetes, and was experiencing significant hyperglycemia, which was controlled. Patient was seen by PT and OT initially felt patient required subacute rehab, ultimately he improved and they recommended home healthcare. Patient was discharged home on 4/1/2023 in stable condition. Follow up with PCP prn.
pt recvd vax,dose 3, felt fatigue,malaise,ha;BP inc to 150/108;devel fever & exp some confus;MD prescribed altace for BP;c/o chest tightness;to er suqsequently had hypotensive episode which required some resuscitation;ECG nl per wife;inc t;
60 year old male client arrives to vaccination site requesting 2nd dose in Moderna series.  Client reports that approximately 1 week after receiving his 1st dose of Moderna vaccine, that he experienced a localized infection at the injection site on his right arm.  Client reports seeing Primary Care Provider who provided treatment of antibiotics for a few days.  Client reports that infection resolved after completion of antibiotics.  Elevated issue to Clinical Supervisor, who received approval from Dr. to proceed with administration of 2nd dose in Moderna series, with administration in left arm.  Second Moderna dose was administered by RN on 11/13/21 at approximately 11:00 AM.  Lot # 066F21A.  Explained emergency precautions to client who verbalized understanding. No adverse symptoms reported during observation period.
Patient reported a reaction at the injection site that included redness, "hot to the touch" and sore. Patient did not report any other symptoms other than those related to the injection site. The patient went to the doctors office for a routine visit on 05/04/2021 and the doctor also looked at their arm and deemed it infected. The patient was started on doxycycline 100 mg capsule - take one capsule by mouth once daily for a 30 day supply. The patient noticed the reaction on 05/02/2021, the day after the immunization. The patient reported it after her doctors appointment but said that it was clearing up and she was feeling better on the day she reported it.
swollen red approx 10 cm diameter rt deltoid mildly erythematous sl warm;
The day of the injection i broke out in hives. 3/9/21   My period started early and lasted for 8 days. It normally lasts for 3. Then I ended up starting early again and am currently and actively bleeding. It has been 8 days again. This started the weekend after I got the vaccine.   Also. In the muscle around the injection site when I lift heavy things it feels like I'm being pinched or hurt. This started April 17th ish.
Head size increased from 5% to 90%, coughing spells, brain swelling, hematomas, multiple fractures of (TBBD). Vitamin C. The ER record received on 3/3/04 states fever, viral illness and dehydration. Hospital record for 12/30/03 states vomiting and mild acidosis.
Recvd 15mos 3SEP91 630PM by 4SEP91 430AM; t103-104 went to ER evening of 4SEP91, t105, listless; On 10SEP91, swelling occurred in leg knee & ankle; returned to MD on 10SEP91;
During an injection procedure, syringe came dislodged from the needle.  It was determined by the vaccinator that majority of the vaccine had been injected.  No additional dose was given.
This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes Zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 11th March 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up via email.
Severe pain under the left arm in the armpit. Pain is radiating down left arm close to the elbow as well as the upper left back and left chest area. Limited movement in left arm.    Fever Chills  Body aches
Collar bone sore. Bump on left side of neck. C/o of pain with intensity x 2 days.
6/29 - minutes after injection given redness and swelling at injection site; 7/5/18 - pt calls painful rash all over body - told to take BENADRYL; 7/16/18 - Dr. appt rash comes and goes with sore throat, swollen glands, myalgia, skin lesions; 7/17/18 - phone call pt c/o continued rash, swelling Lt arm, chills, occasional hallucinations - refer to ED; 7/20/18 - pt calls c/o Rt hand swollen, feverish, joints painful, fatigue - appt scheduled for 7/21/18.
No Adverse effects noted, Resident administered expired Moderna Vaccine expiration date 10/13/2021.
constant pain in lower back around the back hip area. Left hand is very soar, fills like arthritis.
3/9/21: 1:05pm: Nerve-like pain immediately neck to fingertip. 5pm--extreme arm soreness for 3 days; less extreme soreness still present at 7 days. 3/10/21: 2am: fever, chills, body aches, headache, fatigue, weakness for 48 hours. 3/13/21: golf ball sized redness at site of shot, intermittent itchiness/soreness
Patient with immediate dizziness after receiving the vaccine.  Patient was observed for 45 minutes. Patient was lying  supine the entire time.  After providing patient with 3 cups of water, and him eating candy that he brought along, patient was still not improving much.  Doctor was brought into the exam room to access.
Patient was given a bivalent Pfizer as a dose 2 instead of a monovalent
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized with acute hypoxemic respiratory failure due to COVID-19. Received remdesivir, steroids, and supplemental oxygen. Discharged home medically stable.
This case was reported by a other health professional and described the occurrence of extra dose administered in a female patient who received ENGERIX B (batch number F2LR7, expiry date 9th October 2016). In October 2014, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: HCP at dental office given one dose of ENGERIX-B two weeks ago as she did not have documentation that she had previously been vaccinated. She then brought documentation of the series completion 10yrs ago. No patient details immediately available.
Allergic reaction to COVID-19 Moderna vaccine occurring on 06 Jan 2021. Symptoms include: nausea, vomiting, headache, facial swelling, dizziness, and low blood pressure. Treated at ER with benadryl, epinephrine, sodium chloride, zofran, toradol, solu-medrol medications
Left arm numbness, lazy right eye, difficulty swallowing, dizziness, nausea and vomiting.
6SEP91 pt recvd 1 dose of Engerix-B & 1-2 days p/inject pt devel hives & a non-specific reaction to abdominal area w/no other sx;
2-1-13 Eve, itching, muscle pain. 2-2-13 Lt upper arm generalized pain#7 with movement at #4 rest. Red inflammation.  2-2-13 pm - hospital. Treated with AUGMENTIN oral -> IV penicillin & Doxycycline, prednisone - Not admitted. To PCP GI Doc - NLT from work.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 14-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Patient complaint - pain left shoulder. MD visits - no signs of swelling, erythema. Tenderness. Pain noted with passive abduction, limited active internal rotation. Diagnosis bursitis secondary to flu vaccination treated with KENALOG injection into sub deltoid bursa.
Case number PHEH2014US003869 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 13 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 006031A), intramuscularly on 23 NOV 2013. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Information has been received from a pharmacist and physician concerning a child who on 8/11/03 was vaccinated SC with a dose of varicella virus vaccine live. On 9/4/03, the patient developed a non-specific erythematous rash with chickenpox sized pustules. The rash was described as 4 erythematous papules on the chest, 2-3 of the same on the lower extremity and one on the face. Three days later on 9/7/03 the child developed non-severe ataxia and was hospitalized. The CSF was normal and the child recovered from the ataxia within 24 hours. The patient had CSF, skin lesion swab and rectal swabs sent for culture and all results are pending. On 9/8/03, the patient was discharged from the hospital and the rash was healing. The physician reported that the child was a normal host by history and did not have a history of recent illness or viral infection. There was no product quality complaint involved. Additional information has been requested.
After receiving second shot,  had a temperature of 101.5, 'everything hurts' and 'feels horrible.'  Unable to work scheduled shift.
mom reports that the patient complained of not feeling well the night the vaccine was given, with mild errythema and swelling. Patient had intermittent pain to her Left arm (site of vaccination) that continued to the next day. tempurature was 99.4, site of injection on 8/18/20 was more swollen, red, warm and painful. complained of mild puritis. has history of receiving flu vaccines with no previous reactions. PainEase spray was used prior to vaccine administration and patient has also used it in the past without incident.
pain; chills; aches; got positive COVID result; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got positive COVID result), CHILLS (chills), MYALGIA (aches) and PAIN (pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included POTASSIUM, COLECALCIFEROL (VIT D3), DICLOFENAC, LETROZOLE, LOSARTAN, GLYBURIDE, SITAGLIPTIN PHOSPHATE (JANUVIA), METFORMIN, CARVEDILOL, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), SUCRALFATE (CARAFATE), ACETYLSALICYLIC ACID (ASPIRIN 81), AMLODIPINE, PROMETHAZINE, FISH OIL, CYANOCOBALAMIN (VITAMIN B12 AAA) and CALCIUM, MAGNESIUM, ZINC (CALCIUM MAGNESIUM ZINC [CALCIUM;MAGNESIUM;ZINC]) for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced COVID-19 (got positive COVID result). On an unknown date, the patient experienced CHILLS (chills), MYALGIA (aches) and PAIN (pain). At the time of the report, COVID-19 (got positive COVID result) had resolved and CHILLS (chills), MYALGIA (aches) and PAIN (pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.; Sender's Comments: This case concerns a 70 year-old, female patient with no relevant medical history, who experienced the non serious unexpected adverse event of special interest of COVID-19. The event occurred approximately 28 days after the first dose of Moderna COVID-19 vaccine. The rechallenge was unknown since the event occurred after the first dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
dry cough started-1/6/2021 7:30pm-now deep bronchial cough overall muscle and joint achiness started 1/7/2021 5pm low grade fever (99.9) 1/7/2021 at around3pm nausea and diarrhea 1/8/2021 11am general malaise-started 1/7/2021 early morning
Caller verified that she is still within the 5-day period since symptom onset; Caller verified that she is still within the 5-day period since symptom onset; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN; ROSUVASTATIN [ROSUVASTATIN CALCIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Caller verified that she is still within the 5-day period since symptom onset".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & on 7APR afternoon 5-6 hrs later woke up from a nap, suddenly became listless & pale; just stared ahead, didn't seem to fix; became blue;
48 hours erythematous rash, blanching confluent; No hives, chest, arms, back, legs, No oral lesions; "Sandpaper"; Strep (-)
Health Nurse requested me to take Flu Shot and I was concerned that with my poor immune system I would get the Flu. Health Nurse swore I would not get the Flu, and that since I worked as a MH/SA Emergency Clinician in the county jail I was at high risk of catching the Flu. That night I was terribly sick with fever of 107.5 (for the second time in my life.) I had the Flu and called my Doctor about fever and he didn't really give me advice so I had roommate put ice in a cold bath to try to break the fever. I only remember waking up the next day with a severe Flu. The day before vaccinations was my last healthy day. Dr. diagnosed me with SLE Lupus, Psoriatic Arthritis, etc. Disabled 04/07/1997.
Pt stated arm was sore right after shot and continued to be sore. Pt stated when she changed her clothes in the am, two days later, noted arm was beet red, hot, swollen, from her shoulder to her elbow. Pt stated she called another clinic she goes to urgent care line and was told to ice arm and alternate ibuprofen with tylenol, for pain.
Pt w/hx significant for COPD (on 1L O2 a baseline) p/w cough, exertional dyspnea, and generalized weakness since 6/7/21). COVID test positive on 6/10 despite receiving Pfizer vaccines on 4/5 & 4/27. Pt was admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  During admission received dexamethasone, convalescent plasma, remdesivir.  Culture indicated pseudomonas PNA, but likely colonization given hx, however, due to illness and underlying bronchiectasis, was given cefepime. Hospital stay complicated by significant resistant hypercarbia and respiratory failure, pt placed on comfort measures given that death is imminent. Unfortunately, pt passed on 6/13/21.
Pt was in for pre surgical visit - had PCV 13 on 12/15/15. Woke up feeling achy. (R) arm hurt and heavy chest. Wife brought him into office to determine localized illness vs. reaction.
Pt complained of itching on the palms of her hands a few minutes after receiving flu shot. I asked her to sit for a few minutes and she said it went away in just a few minutes.
Chills, night sweats, no fever, dry cough, lost of smell and taste. Tested positive for COVID-19 on May 20th.
Per patient description, shoulder very sore, achy, motion inhibited, hurts on and off.
Patient is a 47 y.o. female with a history of cervical cancer status post chemo/radiation therapy, depression/anxiety, chronic airway obstruction, OSA on BiPAP, hypothyroidism who presented to ED with symptoms of fever, congestion, sore throat, cough, muscle aches and found to be COVID-19 positive.  Patient did previously receive J&J COVID-19 vaccine on 7/15/21 but had not yet received booster. Desaturation noted with ambulation, so admission was requested for further care. CXR normal. LFTs mildly elevated. She received decadron in the ED but was not continued on steroids upon admission given lack of hypoxia. CT angio negative for PE or other acute abnormality. She did receive benadryl and solumedrol as pre-treament for IV contrast allergy. Following the CT, she noted itching of hands, feet, and eyes along with hand swelling and erythema. Planned epi and pepcid, but patient felt better and declined these medications. Allergy profile updated. She remained stable on room air. Labs stable/improving. Planned discharge on 1/21 but patient was feeling symptomatically worse, with stable vitals. She was monitored an additional night and remained stable on room air. She felt comfortable with discharge home on 1/22. She will arrange PCP follow up for hospitalization and was discharged in stable condition.