chrisvoncsefalvay/vaers-outcomes huggingface dataset:
October 5, 2015 Vaccinations for flu and pneumonia at dr. office, both injections in left arm. October 6, 2015 Can not move left arm, very painful, can barely walk, left leg does not seem to work well, almost fell on way to bathroom. Felt as if I has no control of the movements of the left side of my body. No change for 7 days as I spent all the time in a recliner. October 14, 2015 Can now lift my left arm approximately 6 inches, left leg is beginning to work but does not synchronize with my right leg while trying to walk. Soles of feet have stinging sensations constantly and skin feels as if it is being poked with needles. My right side is starting to respond similarly to my left side. My arms feel as if they are asleep for a couple hours at a time. Sometimes hands and feet will tingle for an hour or so. I have no sensation in my fingertips, I can not feel things. My fingernails have broken to the quick and are not growing. October 30, 2015 I can lift my arms high enough to put on shirts, but is very painful. My left arm hurts constantly. Nov. 11, 2015 My legs seem to work together  a little better. There have been two instances when everything seemed to be working fairly well and without ant warning both legs just seemed almost paralyzed. One time I was at market and did not think I could get to my car in the parking lot. This frightened me so much that I now carry a folding cane at all times. Nov. 16, 2015 I had a dr. appointment today. The dr. had an intern student on staff that day. She was sent in to see me. I was in terrible condition and I told her about all of my symptoms. She talked with me for about 30 minutes. She recorded all of the information into the computer. The dr. entered the room and stated that this was going to be a short visit- Do you need any medication refills? He did not examine me, I question his examination report for that day. Nov. 22, 2015 I am now having bladder problems. I can not keep my urine stream going. It is difficult to start urinating, and then the flow stops, sometimes I start and stop urinating 9-10 times before I can empty my bladder. This occurs event if  my bladder seems very full. I have never had this problem previously and I have not had any medication changes. It is a struggle to ensure that I get my bladder empty. Today I went to the bathroom, when I pulled down my pants I was surprised to discover that I had soiled my pants. It was very runny, I had not passed gas, I did not know it had happened. Now I fear it will happen when  I am not home. Dec. 6, 2015 I think I have a bladder infection, but a trip to the dr. and a urine test does not indicate an infection. Even though I have had muscular pain for a few years, all of the new pains are completely different. I hope these new pains recede soon as I just seem to be getting weak and do not seem to be seeing any improvement. I have started physical therapy, trying to improve my legs. Jan. 6, 2016 I had an MRI today, to check for any physical reason that my bladder does not work correctly. Nothing was identified on the MRI.
No known reactions at this time. Patient received Moderna vaccine 10 MAR 2021 and never completed the Moderna series. Patient received Pfizer vaccine today at our clinic because of benefits.
admitted 2/15 with cough, leukocytosis, chest x-ray unremarkable, CT angiogram without consolidation, ongoing desaturations hypoxia noted, findings of severe sepsis secondary to to this from presumed pulmonary origin. We initiated IV antibiotic therapy, pulmonary consulted, respiratory viral pathogen negative, echo showed mild pulmonary pretension, nocturnal hypoxia noted suspicious for OSA in setting of obesity.  Will discharge on 2 L nocturnal, with upcoming OSA evaluation ordered. Patient improved through hospital course, was discharged home with nocturnal oxygen support given to find hypoxia on overnight oximetry study. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Right interior thigh erythematous and indurated to 12 X 15 cm.
Vertigo, mild headache, mild nausea. Sudden onset, subsided after 30 minutes.  Some remains after several days.
Information has been received from a physician concerning a 23 year old health female who on 26-AUG-2008 was vaccinated with the first dose of GARDASIL (lot# 660555/0279X). Concomitant therapy included DEPO-PROVERA (not administered with GARDASIL). Later that day, on 26-AUG-2008, the patient had dizzy spells and vision changes lasting for 2 weeks. She had no headache. The patient's blood sugar was normal. She reported these symptoms to the physician after they had already resolved. Additional information has been requested.
Dizziness, fatigue. BP 84/58 (pulse 64), final BP 110/70. Orange juice, crackers, and water given. Low BP observed for past few days.
Flu-like symptoms; Fever; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Patient presented for outpatient left heart cath on 12/8/21 to assess worsening exertional chest pressure/discomfort. The workup revealed multi-vessel coronary artery disease with left main involvement  and severe aortic stenosis.  On December 10 the patient was admitted and underwent CABG and AVR. The patient was extubated shortly following surgery in the ICU.  The mediastinal chest tubes were removed on POD #1 when the drainage was sufficiently low. The patient was weaned off vasoactive drips as tolerated.  Hospital admission was within 6 weeks of receiving the COVID vaccine.
Patient was with her daughter to get a high dose flu shot and a tdap (Boostrix) vaccine.  Pharmacist first administered a Fluad shot in her right arm.  Then I  reached back to get Boostrix vaccine to administer in her right arm.  In error I picked up her daughter Flucelvax vaccine.  As I injected the vaccine I realized that I had accidentally given her a second influenza rather than a Boostrix vaccine.
Felt like the flu. Cold chills and a fever. No nausea. Bad for 1 day the next day better. Day 3 100% ok.
Tightening of jaw, stiffness in knees, back and neck. Increased breathing, general anxious or nervous feeling.
DX: CVA History The patient is a 92 y.o. female with a past medical history notable for  History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.
Inadvertently used 1/2 inch needle instead of a 1inch needle to administer the vaccine to 20 patients; Concerned if those injections were subcutaneous; A spontaneous report was received from a consumer concerning 20 patients , who received Moderna's COVID-19 vaccine using a ½ inch needle.  The patients identity, medical history were not provided. No relevant concomitant medications were reported.  On an unknown date, 20 patients received their first dose of two planned doses of mRNA-1273 1273 (Batch number not provided) for prophylaxis of COVID-19 infection by the Pharmacist.  On an unknown date, safety received the report that Pharmacist gave the vaccine using ½ inch needle instead of 1-inch needle. He is concerned those given may be subcutaneous as he used wrong technique in device usage and inappropriate of administration. He is provided with medical information needed to administer the vaccine.  Action taken with the second dose of Moderna vaccine in response to the event was not reported. Outcome of the event wrong technique in device usage and inappropriate route of administration were recovered on an unknown date.; Reporter's Comments: This report refers to a case of wrong technique in device usage process and incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Moderna vaccine given to a patient who it was not indicated for since patient was only 17 years of age at the time of the vaccine. No adverse events reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Aug2021 as dose 3 (booster), single (Lot number: EW0191), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 18Mar2022 as dose 4 (booster), single (Lot number: 039f21a), in left arm and on 05Aug2022 as dose 5 (booster), single (Lot number: 064a22a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "mood disorder" (unspecified if ongoing), notes: Other medical history: mood disorder,; "hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypothyroidism; "insomnia" (unspecified if ongoing), notes: Other medical history: insomnia; "obese" (unspecified if ongoing), notes: Other medical history: obese. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: no known allergies.
nurse accidentally gave me a child dose so had to get an adult dose too , no AE; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient who got accidentally INFLUENZA VACCINE (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination in child dose so had to get an adult dose of too on an unknown date (product administered to patient of inappropriate age)  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was unknown if patient s physician provided consent to be contacted and age group is actually not provided  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
On 6/15/04: shots given. 6/17/04: pt present with complaint of area LD being red, swollen, blisters, area warm to touch. Rocephine 1cm given. Benadryl 25 mg given. Tolerated well. Pt sent to Medical center on 6/18/04.
See attached. 12/29/06 Protruding disk Left side causing pain down leg. Still had pain Left arm can not apply weight or lie on left side. Sleep 1hr/day. 1st week of November received vaccine-upper arm-extremely sore inside and outside. Could hardly lift it at all. Took TYLENOL, couple of days. Unable to lift behind my back any higher than my waist. Still extremely tendered and "knotty".  Follow-up received states - upper area tender to touch immediately, continued to hurt more as each day passed - resulted in "Frozen Shoulder" required P.T., medication, still hurts today.
We had a 4 month child come into the office for their 4 month well child check. The medical assistant that gave the vaccines gave two extra vaccines. She gave a DTAP and HPV to this child. She also gave the correct vaccines DTAP/IPV/HIB, PCV 13, and Rotavirus. That medical assistant is now back in training, and will not be giving vaccines until further training is completed.
tingling numbness in left arm, then up to jaw and tightening in throat progressing to thick tongue
Information has been received from a physician concerning his 65 year old wife with chloramphenicol allergy who on 10-MAR-2010 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. On 15-MAR-2010 the patient developed red, raised lesions in the distribution of the right arm extending to the right elbow and forearm. The patient also developed pain in the right neck and shoulder which caused difficulty using her right hand. The patient was started on unspecified antiviral medication and NEURONTIN. There were no laboratory diagnostics studies performed. At the time of this report, the pain was slightly improved but the lesions persisted. Difficulty using her right hand was considered to be disabling by the physician. No further information is available.
Severe soreness in arm/shoulder for 3 days and then developed shingles on chest and back.
Severe redness covering entire tricep area, very tender to the touch, painful, swollen, small blisters noticeable at injection site.
Maderna COVID-19 Vaccine EUA  12/30/2020 4:30pm, fast HR, shaky 6:02pm- BP 107/103, HR 95, shaky, lightheaded 6:25pm- BP 154/111 HR 83, shaky and dizzy 6:30 pm- nauseated and dizzy 6:45pm, BP 154/111 HR 85, nausea coming in waves but no vomiting, still shaky 7:44pm- BP 160/97 HR 77, less nausea
Mother reports reddened bruise like area around injection site at top of left arm. It extends downward approximately 1 inch. Sensitive to light touch but no pain with heavier touch. Follow up on 03/18/04: "Mother reports reddened bruise like area around injection site at top of left arm.  Area extends downward approximately 1 inch.  Sensitive to light touch but no pain with heavier touch.  No changes in appetite, sleep or breathing."
Sudden high fever (106 F) with no other symptoms. Low grade fever 72 hrs following injections with recurring sudden onset high fever in early morning hours for 72 hours following inoculations.
This spontaneous report as received from a registered nurse via field representative refers to 40 patients of unknown age and gender. The patients were relocated. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date (also reported as a while ago), the patients were vaccinated with M-M-R II, (dose, frequency, route of administration and indication were not provided). On an unknown date, 40 patients broke out in rashes and fevers, but did not get the measles. The outcome of broke out in rashes and fevers was unknown. Causality was not provided. No further adverse event information was given. This is one of two reports received from same reporter (linked with MARRS# 1503USA013899). Additional information has been requested.
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 28-SEP-2015, the patient received an improperly stored dose of GARDASIL, lot # K005881, expiration date 14-JAN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
High fever 102.  Very painful arm pain.  Itchy hives on arm.  Menstral period started after no period for 2 months
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 02-AUG-2016, the patient was vaccinated with their first dose of RECOMBIVAX HB (lot number reported as L032596, expiration date 02-AUG-2017, dose and route of administration were not reported). On 04-AUG-2016, the patient was inadvertently vaccinated with a second dose of RECOMBIVAX HB (lot number reported as M015775, expiration date 16-JUN-2018, dose and route of administration were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Severe local reaction with cellulitis at site with fever and myalgias. About 6 years ago, required antibiotics.
This spontaneous report was received from a medical assistant concerning an 18 year old patient of an unknown gender. Medical history, concurrent conditions and concomitant medications were not provided. On 20-FEB-2019, the patient was vaccinated with an improperly strength adult dose of VAQTA (incorrect dose administered, and product administered to patient of inappropriate age) (dose and frequency were not reported) lot # R009799, the expiration date: 02-JUN-2019, intramuscularly for prophylaxis. No adverse effects were reported in the patient.
pt recvd inj & devel inj site rxn of redness & swelling. Recovered w/o tx. Reporter indicates 14 people exp this event but are not identifiable at present.
Dose 1 - arm pain on injection site arm Dose 2 - 3 hours after injection severe arm pain on injection site arm, that hand numb 7 hours after injection headache 10 hours after injection - fever 11 hours after injection - severe headache, fever, severe body aches (eyes hurt, teeth hurt, entire body in pain),  continued severe arm pain, teeth chattering, chills - that lasted 36-42 hours 26 hours after injection - nausea and vomiting - lasted 10 hours Week after the injection - headaches, fatigue
Loss of bowel and bladder control, loss of sensory  /motor function below waist except for quads over 4 days then stationary, rash at waist. 4 week inpatient rehab treatment: 3 courses IV STEROIDS 14 days IV acyclovir 14 days.
Patient reported to PCP's office that within first 15 minutes she had bumps, redness and itching that occurred on her neck. Within the next couple of hours, she reported  Numbness tingling of lips and tongue.  Lips were swollen.  No shortness of breath.  Arm soreness next day. All other symptoms had resolved.
He became very weak and kiss all strength and mobility in his legs. Increased confusion and inability to concentrate. This also happened after the first vaccine and went away the following day.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Information has been received from a male patient of unknown age with high blood pressure, gout and diverticulitis, referring to himself. On 15-JAN-2016 the patient was vaccinated with a dose of PNEUMOVAX 23, on time injection, (dose, dose #, lot #, route and application site were not reported). Concomitant medications included unspecified medications to treat high blood pressure, gout, and diverticulitis. On 15-JAN-2016 the patient experienced joint pain, muscle aches, and pain in his upper chest. The patient also experienced diarrhea and a "bloating" feeling. No medical attention was sought. No treatment was given for events. No lab tests were performed. The outcome of the events was reported as not recovered/not resolved. The causality was not reported. Additional information is not expected because patient wishes to remain anonymous and did not disclose the name of the physician.
pt recvd MMR vax & devel fever of 103 & was lethargic; sx lasted for 3 days & pt recovered; no further details were provided;
VACCINE ADMINISTERED TO 16 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no medical history. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced vaccine administered to 16 year old subject. On 02-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 16 year old patient was not reported. This report was non-serious.
had ice cream again today and was feeling nauseous; had ice cream yesterday and had a bad upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (had ice cream yesterday and had a bad upset stomach) and NAUSEA (had ice cream again today and was feeling nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (hand). Concomitant products included PARACETAMOL (TYLENOL) for Surgery.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (had ice cream yesterday and had a bad upset stomach). On 04-Mar-2021, the patient experienced NAUSEA (had ice cream again today and was feeling nauseous). At the time of the report, ABDOMINAL DISCOMFORT (had ice cream yesterday and had a bad upset stomach) and NAUSEA (had ice cream again today and was feeling nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications was not provided by the reporter   This case was linked to MOD21-044476 (Patient Link).