chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Retinal stroke; blind; sore; feeling bad/feeling terrible; dizzy; This spontaneous case was reported by a patient and describes the occurrence of RETINAL ARTERY OCCLUSION (Retinal stroke) and BLINDNESS (blind) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE from 04-Aug-2023 to an unknown date and ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC) from 04-Aug-2023 to an unknown date for Blood pressure.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 RETINAL ARTERY OCCLUSION (Retinal stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (blind) (seriousness criterion medically significant), PAIN (sore), FEELING ABNORMAL (feeling bad/feeling terrible) and DIZZINESS (dizzy). At the time of the report, RETINAL ARTERY OCCLUSION (Retinal stroke), BLINDNESS (blind), PAIN (sore), FEELING ABNORMAL (feeling bad/feeling terrible) and DIZZINESS (dizzy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that two weeks after the 2nd shot, he had a flash of light and went to the emergency room and was told he had a retinol stroke.He eventually got some vision back in the left eye, but he was left with slight vision problem in the left eye. He was legally blind in the left eye. It was reported that after the second vaccine he went from a healthy man to an old dependable on others to live, person.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 67-year-old male patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization) unexpected, event of retinal artery occlusion and the serious (due to medically significant) event of blindness, which occurred approximately 2 weeks after a dose of mRNA-1273 vaccine, received as the second dose of COVID-19 vaccination schedule, together with other non-serious events. It was reported that two weeks after the 2nd shot, he had a flash of light and went to the emergency room and was told he had a retinol stroke. It was reported that approximately 2 years after the events, he eventually got some vision back in the left eye, but he was left with slight vision problem in the left eye. He was legally blind in the left eye. The outcome of the event was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fell down in her drive way (14 days After first dose)/ I was in an accident; Second dose scheduled  for 154 days after the first dose; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENT (Fell down in her drive way (14 days After first dose)/ I was in an accident) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ACCIDENT (Fell down in her drive way (14 days After first dose)/ I was in an accident) (seriousness criteria hospitalization and medically significant). In July 2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose scheduled  for 154 days after the first dose). At the time of the report, ACCIDENT (Fell down in her drive way (14 days After first dose)/ I was in an accident) and INTENTIONAL PRODUCT USE ISSUE (Second dose scheduled  for 154 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided. No Treatment information was provided. Patient missed her second Moderna COVID-19 Vaccine dose. She made an appointment for 20-Jul-2021 to receive the second dose at a local Pharmacy.  Very limited information regarding  these events have been provided at this time. No further information  is expected at this time.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non significant follow up On 16-Jul-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field; Sender's Comments: Very limited information regarding  these events have been provided at this time. No further information  is expected at this time.
In days after receiving vaccine he reported chest symptoms and changes to chronic breathing. nearly 3 months later he was admitted to hospital with CHF for first time in setting of COPD requiring oxygen and afib at baseline, and an addition 2 months later was admitted with acute on chronic hypoxia in found to have a pneumonia he could not recover from and died from cardiac arrest.
Patient came in for second dose of Vaccine. Upon injection, the hub of the syringe became faulty and vaccine leaked out. Per the nurse, the patient received approximately 0.2mL of the vaccine. Pharmacist notified and aware of the situation; she gave the okay for the nurse to redose the patient. Patient aware of the situation and was comfortable with a redose.
Information has been received from a licensed practical nurse concerning a female employee who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the patient failed to seroconvert. The nurse also report another female employee who had a similar experience after therapy with varicella virus vaccine live (WAES #0312USA02131). Additional information has been requested.
In the evening after the 2nd injection, I began experiencing a phantom smoke smell. No one else in the household can smell it. This has been on-going for 2+ weeks since then. Smoke smell in nose and eye and throat irritation.
next day she was tired; next day she was / sleepy; her arm became  itchy; her arm became  / red; her arm became  / warm; her arm became  / swollen; Itchy rash; chills; This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2021, immediately after receiving Shingrix, the patient experienced itchy upper limbs, erythema of extremities, skin warm, swelling arm, itchy rash and chills. On 18th July 2021, the patient experienced tiredness and sleepiness. On an unknown date, the outcome of the itchy upper limbs, erythema of extremities, skin warm, swelling arm and itchy rash were not recovered/not resolved and the outcome of the chills, tiredness and sleepiness were recovered/resolved.   It was unknown if the reporter considered the itchy upper limbs, erythema of extremities, skin warm, swelling arm, itchy rash, chills, tiredness and sleepiness to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient.  The patient received Shingrix in right arm and arm became itchy, red, warm and swollen shortly thereafter.  The patient experienced chills the same evening and next day the patient was tired and sleepy.  The reporter was referred to health care professional. The reporter did not consent to follow up.
At 2 minutes after administration, site of injection became increasingly red. Child was crying unconsolable. Splotchy, red rash forehead, scalp, face, neck and right arm. 5cc Benadryl given  After about 1 hour, pt calmed, took Pedialyte, splotcy area disappeared.
Patient was vaccinated approx 9a. Later that evening, patient was having trouble breathing so they called son who lives down the road to come, 20 mins after the call the patient has passed. Per medical examiner, pt died due to possible PE, MI, or his aortic aneurysm ruptured.
1.  Acute hypoxic hypercapnic respiratory failure, ARDS: -Pulmonology consulted and following. -7/31 intubated -8/4 extubated  -8/16 re-intubated    2.  COVID-pneumonia: -Infectious disease consulted -+7/31 COVID -Decadron, remdesivir completed    3.  Sepsis, septic shock, bacterial PNA: -Receiving antibiotics -Received pressors -sputum cx with yeast, started on diflucan    4.  Recent transesophageal fistula, status post esophageal stent placement, history esophageal cancer: -Prior admission found to have transesophageal fistula and transferred to hospital, hospital placed esophageal stent -ICU team discussed with recent CT surgeon at hospital -Follows with clinic for immunotherapy   5.  AKI: -Monitor labs -Hold nephrotoxic agents, IV fluids  6. Coffee ground emesis: -GI consulted -no plan for EGD at this time d/t high risk re-intubation -cont PPI BID   7. Dysphagia: -unable to tolerate tube feeds, recurrent aspiration -TPN restarted   8. Other chronic medical conditions: History anxiety, history of asthma, history of non-Hodgkin's lymphoma, depression history, hypothyroidism, OSA           History of Present Illness:  Patient is a 46 y.o. female    Despite all medical treatment and attempt to transfer patient to clinic.  Patient continued to decline medically.  Patient and family followed by palliative care and decision made to transition to hospice.  Patient admitted to IP hospice.
Shingles (herpes zoster) on face. Pain beginning in eye on 11/20/21 and symptoms lasting ~3 weeks from onset. Symptoms including severe pain and rash. Diagnosed 11/27/21. Treated with valacylovir,
Received immunization and had a 5 inch diameter red, warm, hard lump; no fever.
arm itched-on 28OCT95;arm swollen deltoid to elbow, beet red;28OCT95 went to ER, rx DPH, cold pack, Biaxin;one big lump some itching;problems is one inch below inj
?allergic reaction w/red raised areas on skin noted 2 days later also on amoxicillian x 7 days; ? allergic reaction to vax or Amoxicillin; started on DPH 2AUG93;
DIZZINESS; NAUSEA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and dizziness was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L045953; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 73 years old female patient with anemia and sulfa allergy. The patient was vaccinated with pneumococcal vaccine (manufacturer unknown and PNEUMOVAX 23 could not be ruled out) in approximately May 2011 "2 and 1/2 years ago" for doctor's recommendation. Route and lot # were unspecified. On the same day as vaccination, the patient experienced right arm blew up from swelling that was from the shoulder to down the elbow. BENADRYL was given as treatment. The patient was recovered on an unspecified date. The patient sought medical attention via offer visit. Additional information is not expected.
Pfizer (Comarty) booster administered into left shoulder (3rd shot for patient).  First two shots administered in MAY21 (Moderna).  Significant edema occurred following booster.  Left side of body swelled (shoulder, arm, breast, latismus dorsi), edema lasted 5-7 days.  Two months following the vaccine patient had blood markers tested and observed elevated troponin and NT PROBNP indicating heart damage.  Patient had contrast MRI to assess heart condition and was diagnosed with Pericarditis.
Patient is a 75 y.o. female patient of, DO with history of breast cancer, anxiety, depression, GERD, vascular dementia, stroke, MI, subdural hematoma, seizures, and Afib on coumadin presented to Hospital as direct transfer from short stay unit for an episode of A fib with RVR. Her tachycardia improved with IV metoprolol and her home dose of her betablocker was increased to 50mg BID without recurrence of her tachycardia. She was provided with remdesivir and prednisone. She completed 2 days of remdesivir and was discharged home to complete a 5 day course of prednisone. Recommended follow up with cardiology, PCP, and oncology as needed outpatient.   Acute Hypoxic Respiratory Failure - resolved Covid-19 Virus Infection Date of onset of symptoms: 6/11/2023 Symptoms present on admission: shortness of breath Date of covid positive test: 6/11/2023 Vaccination status: vaccinated Imaging: CXR with streaky opacities bilaterally Oxygen requirements on admission: RA Current oxygen requirements: RA (has been for 24 hours) Medical therapy: patient has confusion and memory loss with dexamethasone, remdesivir not initiated on admission Consultants following: none Anticipated special isolation end date: 6/18/2023 Required oxygen overnight on 6/13 for desats to 88% ID consulted, appreciate recs Provide one more dose of remdesivir Complete final dose of prednisone on 6/16 at discharge Paroxysmal Atrial Fibrillation - improved Acute event evening of 6/11 with response to IV metoprolol Elevated HR overnight on 6/12, required 10mg lopressor Has stayed in FACILITY after med adjustments on coumadin therapy INR therapeutic Pharmacy to dose warfarin Continue to monitor on tele Will hold off on cardiology consult given hemodynamic stability Continue increased home lopressor dose at 50mg BID   Acute Diastolic Heart Failure Follows with cardiology Recent Echocardiogram on record with EF of 55-60% Patient reports having echocardiogram in state as well that was reportedly normal Was placed on oxygen at short stay unit CTPA without evidence of PE; trace pleural effusions Lasix switched to PO daily Daily weights Strict I's and O's Will defer echocardiogram given recent study findings in March 2023   Breast Cancer Follows with oncology S/p left partial mastectomy and sentinel lymph node biopsy on 9/2022 S/p meniscectomy on the right Continue home anaztrozole   Hyperglycemia No history of diabetes SSI during hospital stay A1c in March was 6.1   Seizures Seizure free for several years Continue home lamictal Seizure precautions   HLD Will hold statin as patient was receiving paxlovid
Had severe pain in left arm to the point when she could not lift her arm the night of the shot. By the time she came into the office, the arm was feeling better. The arm at that point was just sore.
Swollen knee; 10 to 12 bruised lines on left leg; Swelling of injection site; Itchy Injection Site; rash on injection site; Hard at injection site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen knee), CONTUSION (10 to 12 bruised lines on left leg), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PRURITUS (Itchy Injection Site) and VACCINATION SITE RASH (rash on injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and AMLODIPINE for Blood pressure high, VIT D [VITAMIN D NOS] for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced JOINT SWELLING (Swollen knee), CONTUSION (10 to 12 bruised lines on left leg), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE RASH (rash on injection site) and INJECTION SITE INDURATION (Hard at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. On 03-Mar-2021, CONTUSION (10 to 12 bruised lines on left leg), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PRURITUS (Itchy Injection Site) and VACCINATION SITE RASH (rash on injection site) had resolved with sequelae. At the time of the report, JOINT SWELLING (Swollen knee) and INJECTION SITE INDURATION (Hard at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Physician advised not to take the second shot.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information On 11-May-2021: Email address and address of the reporter was added. Age , height, weight of the patient was added. Ethnicity and race of the patient was added. Past medical history was added. concomitant medication was added. Losartan medication description and dose  was added.  Events outcome updated to recovered with sequelae. Treatment drug was added. On 25-Jul-2021: Non-significant follow-up appended
Headache, Fever, NauseaVomiting, N/V, HA, fever, chills, fatigue, body aches with 1st & 2nd doses - worse with 2nd. Narrative:
Patient received Infanrix instead of Boostrix; 60 year-old female patient received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 60-year-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1 June 2022 Reporter's comment: The Lead Nurse reported that the patient received Infanrix by error instead of Boostrix. The HCP did not know which number of Dtap was this last shot on patient´s history. The reporter consented to follow up by email. Additional Supportive Information: The patient received Infanrix by error instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration.
Local erythemous rxn 2" x 2" warm to touch, enlarged axillary glands; full ROM; onset of temp 17APR91 330-4PM-102;
RECEIVED SECOND GARDASIL INJECTION, AFTER WAITING 15 MINUTES, WALKED TO FRONT TO CHECK OUT, MY DAUGHTER FAINTED, CHIN AND JAW HIT FLOOR FIRST. CAUSING A LACERATION TO HER CHIN THAT REQUIRED 4 STITCHES. Broke a tooth.
She cant walk or clothe without pain; skin on torso hurts so bad; really bad foot spams; nausea; sick; dizziness; sore throat; shallow breathing; constant urge to urinate; body pain; horrible headache; rash; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing) and MICTURITION URGENCY (constant urge to urinate) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash). On 28-Apr-2021, the patient experienced ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing), MICTURITION URGENCY (constant urge to urinate), MUSCLE SPASMS (really bad foot spams), NAUSEA (nausea), MYALGIA (body pain) and HEADACHE (horrible headache). On an unknown date, the patient experienced GAIT DISTURBANCE (She cant walk or clothe without pain) and PAIN OF SKIN (skin on torso hurts so bad). On 03-Apr-2021, RASH (rash) had resolved. On 30-Apr-2021, ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing), MICTURITION URGENCY (constant urge to urinate), MUSCLE SPASMS (really bad foot spams), NAUSEA (nausea), MYALGIA (body pain) and HEADACHE (horrible headache) had resolved. At the time of the report, GAIT DISTURBANCE (She cant walk or clothe without pain) and PAIN OF SKIN (skin on torso hurts so bad) outcome was unknown.            No treatment information was available. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
This spontaneous report was received from a physician assistant, a 63 year old male patient reporting on himself. The patient's concurrent condition included sciatic nerve pain since a year. The patient did not had any drug reactions/allergies. On approximately 26-MAY-2015 (reported as began 6 weeks ago), the patient began to experience "sciatic nerve pain" which he was experiencing now. On 29-JUN-2016, the patient was vaccinated with ZOSTAVAX 19400 plague forming unit (PFU), (dose, lot # and expiration date unknown) subcutaneously in the left upper arm. There was no concomitant medication. In approximately 2016, the patient's sciatic nerve pain had improved after receiving ZOSTAVAX (Therapeutic response unexpected). On approximately 05-JUL-2016 (reported as two days ago), the patient's sciatic  nerve pain became worse after standing on his feet for nine hours. No laboratory tests were performed. The patient did not sought medical attention from his physician and was taking over the counter ibuprofen, naproxen and was also using heat. The outcome of the events was unknown. Causality was not provided by the reporter. Additional information is not expected as consent to contact was not provided.