chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to an 80 year old male patient. The patient's medical history included blood pressure abnormal and severe muscle pain after use with unspecified statin medication. The patient had 2 prior boughts with shingles and patient took a prior prednisone (manufacturer unknown) regimen before receiving the vaccine. On 22-AUG-2013 the patient was vaccinated with ZOSTAVAX, vial, 0.65 ml (standard dose), injection, lot # and frequency unspecified. Concomitant therapies included prednisone (manufacturer unknown), acetaminophen, NORCO, unspecified blood pressure medication, "Pertonic", and unspecified water pill, and an unspecified potassium pill. On 22-AUG-2013, after receiving the ZOSTAVAX vaccine, he began to "feel like he was coming down with the flu". The patient felt as stuffiness in his eyes and head, the beginning of a sore throat, and slight discomfort in his chest. The symptoms were begun on a consistent basis in the evenings. Treatment of 20 mg daily of prednisone (manufacturer unknown) was given for the events. Routine blood work was taken and with normal results. Patient sought medical attention via office visit. The outcome of the events was reported as not recovered/not resolved (also reported "the symptoms had lessened some/lighted up since the, but this still happened as night"). Additional information has been requested.
mild chest pressure; injection site discomfort; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (mild chest pressure) and INJECTION SITE DISCOMFORT (injection site discomfort) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (mild chest pressure) and INJECTION SITE DISCOMFORT (injection site discomfort). At the time of the report, CHEST DISCOMFORT (mild chest pressure) and INJECTION SITE DISCOMFORT (injection site discomfort) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications information was reported.    It was reported that the patient was experiencing injection site discomfort and mild chest pressure for 2-3 days.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form. At the time of the report, MYALGIA (sore arm) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to US-MODERNATX, INC.-MOD-2021-073616 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073616:2nd dose case
Received shot on 11/3/00 at 12:30 and on 11/5/00 at 23:00 became ill. Vision was blurred and then room began to spin to right, vomiting; symptoms repeated for 2 weeks. Dx'd with vertigo secondary to encephalitis in 1968.
Information has been received from a medical assistant concerning an approximately 15 year old female who in approximately 2007, "about a year ago," was vaccinated with a first dose of GARDASIL. On the same date experienced a stroke with unspecified symptoms. The patient was hospitalized for treatment of the stroke and underwent open heart surgery. The patient suffered a second stroke (date unspecified) subsequent to the open heart surgery. At the time of the report the patient was recovering. Additional information has been requested.  8/08/2008 MR received for DOS 8/22-9/12/2007 with D/C DX: Infective endocarditis 2' to Streptococcus sanguinis infection.  Left sided CVA 2' to embolic stroke from mitral valve thrombus.  Moderate to severe mitral valve regurgitation.  Residual R upper extremity weakness 2' to L sided CVA.   Pt presented to ER with c/o severe H/A as well as right-sided weakness, numbness, vomiting and mental status changes. Pt had had some subjective fever with chest discomfort and palpitations over the past 4 weeks. Pt now with confusion and unintelligable language. PE (+) for 3-4/5 muscle strength on R side. 3/6 holosystolic murmur. R sided toes not downgoing. Dizziness upon standing, poor short-term memory, slurred speech, blurry vision and intermittant R eye esotropia. Admitted  with dx of bacterial endocarditis and septic ebolic stroke of the L posterior cerebral artery. Concern for seizures with normal EEG. Tx with heparin/lovenox and abx via a Broviac cath with partial resolution of neuro sx. By d/c able to ambulate, but somewhat unsteady gait r/t paresthesias on the R side. Lower extremity strength returning with some residual weakness in the upper extremities.
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 20-Apr-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. On 20 Aug 2020 patient was had positive pregnancy test. Patient had no previous pregnancies.
Pt had erythema, induration and warmth at injection site. No pain. No fever (99.1F) Pt was treated with Keflex since extensive and very warm.
I was tired. I wake up in the middle of night. I could not move. In May, I got the bad headache in the back of head and neck. It was so bad I had to go to the doctor. She did a neuro exam and give me a presentation for my headache. She gave me Flexural for my neck pain. I feel like after I got the vaccine it throw me into full menopause.
Swollen lymph nodes under right arm and into right side of neck within a few days of vaccine. 2 weeks after 2nd vaccine - had episode of chest pain, severe diaphoresis, then severe weakness and inability to speak or move but still aware of surroundings.  Lasted about 10-15 mins.  Had fatigue and mental fog for at least 24 hrs after.  Have had a total of 4 of these episodes with the last 2 including additional symptoms of muscle tightness in jaw and neck, difficulty swallowing.  Have had multiple tests including cardiac work up.  Cleared by cardiologist.  Then started Neuro work up - EEG was abnormal so referred to Doctor.  After last episode on 08/15 went to ER per Doctor to have Prolactin level drawn.  Waiting on results that should confirm if these are new onset seizures.  Being referred to an Epileptologist also for further testing
Overnight woke up with chills and sever pain at injection site; about 5 hrs later swelling at injection sire, continued chills & lethargy
he keeps tripping with his right foot; sometimes things slip from his right hand; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (he keeps tripping with his right foot) and MUSCULAR WEAKNESS (sometimes things slip from his right hand) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced GAIT DISTURBANCE (he keeps tripping with his right foot) and MUSCULAR WEAKNESS (sometimes things slip from his right hand). At the time of the report, GAIT DISTURBANCE (he keeps tripping with his right foot) and MUSCULAR WEAKNESS (sometimes things slip from his right hand) outcome was unknown.            No treatment information was provided.
Patient felt the hives on her face that she already had upon presentation appeared worse. Her face felt warmer noting her upper lip felt the most warm. This occurred soon after injection was given. No lip or tongue swelling, no SOB, chest pain, palpitations or other symptoms noted.
sensitivity to smells; sesnsivity to fragances; sensitivity to chemicals; This case was reported by a other health professional via call center representative and described the occurrence of hyperosmia in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced hyperosmia, fragrance sensitivity and chemical sensitivity. On an unknown date, the outcome of the hyperosmia, fragrance sensitivity and chemical sensitivity were unknown.   It was unknown if the reporter considered the hyperosmia, fragrance sensitivity and chemical sensitivity to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and reports a sensitivity to smells, fragrances, and chemicals.  The reporter consented to follow up.
Pt was diagnosed with Covid on 11/8/22.  She had also been hospitalized from 11/2/22-11/8/22 for acute on chronic respiratory failure, pulmonary edema, and hypotension.  She was discharged back to the nursing home facility on hospice on 11/8/22.  She subsequently died on 11/14/22 at the nursing home.
There was no adverse event following this vaccination.  is documenting this for the purposes of reporting a vaccine error.    Patient reported that they were looking to get their booster. Patient was given paperwork to fill out and then brought back to room. MA confirmed that patient was there for booster but did not have access to Vaccination record of employee. After administering vaccine, employee asked for MA to complete her vaccination card which showed 3 vaccines. Patient received their second booster when they were not indicated for it. No further action needed medically. Patient will not need to receive another booster shot if the CDC updates guidelines.
Pt stated having a "bruised" feeling that radiated down his back and across his chest to his left shoulder. He said the soreness also radiated down his back to his belt line. Pt stated that the soreness was unilateral to the right side of body except his left shoulder. Pt stated soreness went away after about 1 and 1/2 weeks.
Patient received their booster dose  3 months earlier than it is supposed to be given. their second dose date was in 8/23/21. Pt was supposed to get their 3rd dose or Booster dose on 2/23/22. However their received it today 11/17/2021
pt recvd vax; small rash around inject site; had same rxn at both sites when dtp & hib given at separate site for 4 m dose;
Shortly after the immunization she felt ill, had chills and muscle shaking followed by fever to 102. Was given acetaminophen which resolved fever and reduced chills and malaise. Had sweats did not recur. Has warmth and soreness of arms at injection site.
skipped his second vaccine; tingling sensation on his dorsal feet bilaterial/his hands had some tingling along within his face; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling sensation on his dorsal feet bilaterial/his hands had some tingling along within his face) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (skipped his second vaccine) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced PARAESTHESIA (tingling sensation on his dorsal feet bilaterial/his hands had some tingling along within his face). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (skipped his second vaccine). At the time of the report, PARAESTHESIA (tingling sensation on his dorsal feet bilaterial/his hands had some tingling along within his face) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (skipped his second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient came into office on 10/29 c/o pain, redness, warm to the touch and hard feeling near injection site in her left arm. On the day she was given the Prevnar 13 vaccine she had some pain and noticed hardness near injection site. On or around 10/27 she noticed redness spreading throughout the front of her upper left arm, still having pain, hardness and now warm to the touch. In office she was diagnosed with cellulitis related to adverse reaction to vaccine for which she was prescribed Keflex 500 mg and will take 1 capsule every 6 hours for 5 days and then follow up with us again in 2 weeks.
extremely tired; Chills; her arm is hurting and swollen; body is aching; doesn't feel well; her arm is hurting and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 15:53 (Lot number: EW0172) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sickle cell disease" (ongoing), notes: born with this condition; "Asthma" (ongoing), notes: she has had for about 25 years; "Sickle cell anaemia" (ongoing), notes: born with this condition. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "extremely tired"; CHILLS (non-serious), outcome "not recovered", described as "Chills"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "her arm is hurting and swollen"; PAIN (non-serious), outcome "not recovered", described as "body is aching"; MALAISE (non-serious), outcome "not recovered", described as "doesn't feel well". Therapeutic measures were taken as a result of fatigue, chills, peripheral swelling, pain, malaise, pain in extremity.  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Prior vaccinations (within 4 weeks) was reported as none. AE(s) following prior vaccinations were reported as none. It was reported that, caller, reporting on the Pfizer Covid 19 vaccine and who explained that, she got the first shot yesterday and was having really bad side effects. She reported that, she was extremely tired, has chills, her arm was hurting and swollen, her body was aching and she didn't feel well. Caller wanted to report this. The events did not require a visit to emergency room and physician office. Therapeutic measures included that, she was just staying hydrated and resting. Relevant tests were reported as none.  Follow-up attempts are completed. No further information is expected.
First JANSSEN, booster moderna nowpfizer; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First JANSSEN, booster moderna nowpfizer) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First JANSSEN, booster moderna nowpfizer) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First JANSSEN, booster moderna nowpfizer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a Licensed Practical Nurse refers to a multiple unspecified patients, who on an unknown dates were vaccinated for prophylaxis with a dose of ROTATEQ (Lot K009901 exp date: 08-MAY-2016) (dose and route were not reported) that had experienced temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Reaction to the second does.  Chills,  body aches, headaches, and itchy rash from injection site.
Patient was intended to receive a Flu shot and was administered a Covid Pfizer vaccine. Patients mom made aware and wanted patient to receive this vaccine but he does not turn 12 for a few weeks.  Right on the edge of the approved guidelines. No adverse reactions at this time. will follow up tomorrow
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/11/2023 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/11/2023 SHORTNESS OF BREATH J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 SHORTNESS OF BREATH
Loud ringing can't concentrate.  Thumping in the right ear.  thumps for 2-5 min then stops.
Pt had a 3" radius of redness, puffy and hot on RVL where DTAP was given.
Narrative: Patient admitted 9/7 to 9/15 for management of COVID-19 pneumonia despite being fully vaccinated. Patient presented from care facility (tested positive at care facility) due to concerns for hypoxia, with progressive confusion and weakness. In ED hypoxic requiring 4L NC and febrile to 101.2. Patient received supplemental oxygen, dexamethasone and remdesivir. He clinically improved and hypoxemia resolved. During hospitalization also found to have positive urine culture and treated with antibiotics. Discharged to care facility in stable condition on room air. Plans for acute rehabilitation due to severe physical decondition and generalized weakness.
History of Present Illness:  This is a 66y.o. female with a PMH of scleroderma,raynaud's with gangrenous changes,hypothyroid ,sarcopenia ,severe pcm,GERD,hypertension presented to the ED sent by retirement facility for c/o coronavirus concern. Symptoms began about 4 days ago with cough with clear sputum production, SOB and fatigue. Pt is reported to have tested positive today for covid-19 while she was at retirement facility and sent to ED for evaluation. Pt states she is under palliative care 2/2 sarcopenia and would like to remain DNR/DNI. Pt states she has many chronic wounds, most extensively on her bilateral feet. Pt states she was told her right foot is gangrenous however she has opted for comfort management. Pt c/o chronic pain from her wounds. Pt denies fever, chills, chest pain, palpitations, purulent sputum production, abdominal pain, N/V, constipation or dysuria.  In the ED, pt was afebrile and normotensive, pulse ox stable on room air. Albumin 3.3. Troponin 0.01. WBC 14.2. Hgb 10.0. D-dimer 1,984. CTA PE protocol - 1. No evidence for acute pulmonary embolus. 2. Trace bilateral pleural effusions, left greater than right along with bibasilar hazy groundglass and reticular opacities most likely relating to atypical infectious process. 3. Partially visualized biliary and pancreatic ductal dilatation with common bile duct up to 1.9 cm, incompletely evaluated on this exam. Follow-up CT abdomen with IV contrast recommended. 4. Age-indeterminate T10 compression fracture 5. Patulous esophagus with layering fluid in its distal third, likely related to reflux. 6. Postsurgical changes at the right upper lobe. Chest xray - 1. Trace pleural effusions and increased hazy and reticular opacities bilaterally primarily at the lung bases, overall suspicious for underlying infectious process, better seen on CT exam today. 2. Postsurgical changes at the right upper lobe 3. Very subtle T10 age-indeterminate compression deformity, better seen on CT. CT abd/pelvis - 1. Marked dilation of the common bile duct and intrahepatic biliary ducts. Without evidence for discrete obstructing lesion or choledocholithiasis. Recommend further evaluation with nonemergent MRCP. 2. Dilation of the main pancreatic duct, attention on MRCP examination. 3. Trace bilateral pleural effusions. Partially visualized ground glass airspace opacities concerning for acute atypical infection. 4. Moderate colonic stool burden without evidence for obstruction. In the ED, pt was given albuterol NMT and norco 7.5mg
Full body rash 8 days after first dose of Moderna vaccine. Rash appeared first in groin area, then on trunk, head under hair, armpits, joints, back of knees. Painful and extremely itchy. After one week of the rash persisting, it started to go away, but then over the second week it came back, itching more intensely for another week. Went to dermatologist where a steroid injection was given and a dose pack of Prednisone prescribed. Now, 20 days later, rash is starting to go away, but still itches. Dermatologist said appeared like Grover's disease under microscope. When the rash first came on I also developed a severe headache, did not feel well in general, and had to stay in bed for 3 days.