chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her joints started swelling and now she's in a wheelchair; Her left knee is hurting pretty bad right now; Had incontinence right after that shot; She didn't take the 2nd dose on time due to her running a temperature; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Her joints started swelling and now she's in a wheelchair) and ARTHRALGIA (Her left knee is hurting pretty bad right now) in an 85-year-old female 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 Swelling of legs (Legs swelling when she sits down). Concurrent medical conditions included Heart valve disorders (Heart valve problem) and Low vision, one eye (Losing eyesight in her left eye).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INCONTINENCE (Had incontinence right after that shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She didn't take the 2nd dose on time due to her running a temperature). On an unknown date, the patient experienced JOINT SWELLING (Her joints started swelling and now she's in a wheelchair) (seriousness criterion disability) and ARTHRALGIA (Her left knee is hurting pretty bad right now) (seriousness criterion disability). On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She didn't take the 2nd dose on time due to her running a temperature) had resolved. At the time of the report, JOINT SWELLING (Her joints started swelling and now she's in a wheelchair), ARTHRALGIA (Her left knee is hurting pretty bad right now) and INCONTINENCE (Had incontinence right after that shot) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.  Company Comment : Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected events of Joint swelling and Arthralgia and non-serious event of Incontinence, a causal relationship cannot be excluded. The causality for Inappropriate schedule of product administration assessed as not applicable. Patient received 2nd dose and incontinence right after that shot while still at vaccine facility.  She had a problem with incontinence but not that bad.  Four to 5 weeks ago her joints started swelling and then she was in a wheelchair.  Her left knee was hurting pretty bad.   This case was linked to MOD-2021-285156 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected events of Joint swelling and Arthralgia and non-serious event of Incontinence, a causal relationship cannot be excluded. The causality for Inappropriate schedule of product administration assessed as not applicable.
arm is killing patient; fever of 100.6 degrees; achiness; joint pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is killing patient), PYREXIA (fever of 100.6 degrees), MYALGIA (achiness), ARTHRALGIA (joint pain) and FATIGUE (fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is killing patient), PYREXIA (fever of 100.6 degrees), MYALGIA (achiness), ARTHRALGIA (joint pain) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (arm is killing patient), PYREXIA (fever of 100.6 degrees), MYALGIA (achiness), ARTHRALGIA (joint pain) and FATIGUE (fatigue) outcome was unknown.            The action taken with mRNA -1273 in response to the event was not applicable. No concomitant medication information was provided. The patients treatment product information included tylenol.
Patient received Pfizer vaccine at 3:13p. Patient was monitored for 15 minutes. Patient left with no symptoms. Patient returned to vaccine clinic at 4:01p with facial edema. 911 was called at 4:12p and patient taken away by ambulance.
Awoke with trembling in pectoral area about 2:13 am. No temperature, not cold or sweaty. Put on additional clothing, drank water and went back to bed. Shaking disappeared, but felt fatigued remainder of day.
Patient pass out for 5 minutes after getting the COVID vaccination at around noon time.  Pharmacy called paramedic  immediately. Patient regained consciouness before paramedic arived. Patient was oriented to time and place when asked by pharmacist and was offer drink and snack. Patient has dizzy spell and pass mout occasionally per her parent. Paramedic arrived 15-20 minutes after called and after patient regain consciousness BP and pulse was taken. Paramedic waits for patient to become stabilized then left.  Patient walked with her parents to their car and left.
COVID positive on 6/14/2022 . Symptoms - Sore throat and cough. Prescribed Paxlovid.
pharmacist used a smaller needle for the second; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (pharmacist used a smaller needle for the second) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0381C20A and 015N20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (pharmacist used a smaller needle for the second). On 29-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (pharmacist used a smaller needle for the second) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
pt states SOB x 2 days lt upper arm pain/edema/erythema;
About 4 days after the vaccine, suddenly in the middle of the day, I had jaw pain in my left jaw. there is a lot of tightness and I can't open my mouth wide. exactly one week after the vaccine I had a possible TIA. I was observed and underwent testing for a day and a half at the medical center.
Information has been received from a nurse referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K010337, expiry date 22-JUL-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. The outcome of the events was unknown. Additional information has been requested.
Onset of signs/symptoms approximately one hour following Tdap immunization.  Patient experienced visual disturbances, including blurry vision, Euphoria, Abnormal taste in mouth, abnormal smells, anxiety, feeling as though heart was racing, but normocardic. No treatment necessary.
3 d. post immunization noted "aches in both legs-progressing to arms and legs." Tx with ASA with relief. Pt advised by MD to d/c HCT 2.25mg qd started 1 mo age as well as notify health dept. Pt states is "very sensitive" to meds. Pt has rec'd flu vaccine x many years without effect.
shingles; chicken pox; This is a spontaneous report from a Pfizer sponsored program. A contactable 71-year-old female consumer(patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Expiration date: Unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Patient medical history and concomitant medications were no reported. Patient had a condition called shingles chicken pox and Patient currently on a medication of Valtrex and was about to finish taking it on Wednesday. The outcome of event was unknown.   Information on the Lot/batch number has been requested.
Swelling of arm that received injection. No pain. Swelling occurred shortly after vaccination date and subsided a little, but got bigger in the last few days.
While patient was waiting patient had nausea, sweating and lost consciousness for few seconds. We called 911 and let patient lie down on the back with leg lifted on a chair. patient felt ok and EMT checked him out.
Swelling and tenderness at injection site. Also, red, itchy, slightly raised rash around injection site. Had fever, body aches and headache.
Information has been received from a registered nurse concerning a 34 month old female, with  no known drug allergies or medical history who on 06/09/1999 was vaccinated with the first dose of varicella vaccine SC in the left thigh. There was no concomitant medication. On 04/17/201 the pt was seen in the doctor's office with "red rash papules, few with raised centers," which began on her abdomen. It was reported that there were also a few on her arms, back and legs. The registered nurse reported that a few days prior to this the pt had a runny nose, was afebrile and was exposed to chicken pox five days before the rash started. She stated, "probably varicella." The registered nurse reported that the pt received no treatment. Upon follow-up, it was reported that the pt recovered. No further info is expected.
Blurry vision on left eye for couple of days (start date approximate); This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision on left eye for couple of days (start date approximate)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VISION BLURRED (Blurry vision on left eye for couple of days (start date approximate)). On 31-Mar-2021, VISION BLURRED (Blurry vision on left eye for couple of days (start date approximate)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided   This case was linked to MOD-2021-089098 (Patient Link).
Injection site reaction: large, swollen red area around injection site, growing in size since the shot. Sore in that area. More than just general soreness from the shot.
Student had soreness for 24 hrs after injection in area of injection which resolved. Then on 12/14/16 developed soreness in same area that lasted at least 48 hrs. No redness, swelling, fever.
Began as itching between fingers and toes and  progressed to severe itching, rash and swelling on forearms, buttocks, and between fingers.
Burning in back region after first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 12:45 (Lot number: EN 6198) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE; BENEFIBER [CYAMOPSIS TETRAGONOLOBA GUM]; ESTARYLLA. The following information was reported: BURNING SENSATION (non-serious) with onset 22Feb2021 14:00, outcome "not recovered", described as "Burning in back region after first shot". The event "burning in back region after first shot" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of burning sensation.  Additional information: As a treatment for the event,  Gabapentin is prescribed. Mo known allergies and medical history noted.  No follow-up attempts are possible. No further information is expected.
Pt developed redness, itching and mild swelling at injection site within a few minutes of administration. Directed to take benadryl, tylenol, ice by PCP No immediate direct care given.
Patient called Sunday, October 1, 2017 to report they were experiencing the following symptoms: fever, chills, nausea, and painful cough. The fever and chills have subsided but patient still felt nauseous at the time and when they do have a cough, it hurts on her side. Patient took Tylenol for the fever. I recommended patient use emetrol for nausea and the patient has a cough suppressant at home she will use if the cough persists.
Pt's (R) thigh became very swollen and extremely red. Swelling as big as moms hand.
3 days, post vax, the pt developed a low-grade fever (99.1-100.1F) and fussiness. He started hitting the side of his head, like his ear hurt. The morning of the 4th day, post vax, his fontanel was bulging. Went to pediatrician and was sent to ER for CAT Scan, blood and urine work-up and a spinal tap. Over 10cc of spinal fluid was drawn. My son was hospitalized for 2 days to receive antibiotics through an IV and to be evaluated by a neurologist. After fontanel filled, his temperature rose to 103.7F before slowly returning to normal. Immediate symptoms are gone but don't know the long-term effects. Discharge diagnosis on 2/19/02 was hydrocephalus->benign intracranial hypertension and viral syndrome. Annual follow up states it is unknown if pt has recovered. The annual follow up received on 6/19/02 states pt had increased cranial pressure and had another spinal tap 6 weeks after the original incident. He has recently been diagnosed iwth a pseudo tumor.
Immediately after receiving the vaccine I felt A rush in my body and my heart started beating faster and my lips began to tingle. The nurse gave me 25 mg of Benadryl and I also am experiencing itching  all over my body.
Patient is fully vaccinated. Patient developed COVID symptoms around 12/6/21, tested positive two days later.  Patient has a pulse ox at home, reports no hypoxemia.  Today c/o cough, nausea, myalgias, diarrhea for the past four days. Currently no fever, temp at triage 99.2.  HR 84, pulse ox 96%.  RR 22, BP 133/60.  Has been fully vaccinated and received booster. Mild hypokalemia. IV hydration, potassium given. Stable, discharged with instructions.
Patient is 17 years old and has been mistakenly administered Moderna Vaccine  on 4/21/21
10 cm local erythema, edema and pruritis at injection site of left thigh (DTaP injection).  Patient was seen subsequently in ER, treated with oral diphenhycramine and antibiotics.
Patient complained of Fatigue, Soreness, redness and swelling at the site the Menactra was injected.
A bump appeared next to the injection site which quickly disappeared. Called manufacturers. Pt. doing fine.
initial flu symptoms typical of previous dose 8/30 unusually tired 8/31-9/2 flusih, very tired 9/3 no symptoms 9/4 had a series of unusual heart palpitations for two hours in morning (determined to be SVT by cardiologist) resulting in exhaustion for a few hours since that time I have been generally tired and have joint soreness (pain level <1) and I have unexplained SOB, lungs feel like they are may 75% of capacity, sometimes this goes away completely and I feel perfectly normal, but it does not last for more than a couple hours and then I'm back to tired, I continue to have SVTs intermittently
Red warm itchy area approx 6 inches in size at injection site. Headache. No doctor visit at this time.
About  11 days after receiving the Moderna Bivalent Booster, I started to experience hives over my scalp, face, neck, arms and torso and these symptoms are still ongoing into 15 days post-booster.  I have never had hives (redness, itching) like this before.  I am taking hydroxyzine (10mg 4 times per day) to combat itching, redness and raised bumps on skin). Medication is helping but symptoms persist.
fever (100.5), chills, body aches, headache, site injection pain, starting the evening  of the vaccination (April 29) and continuing through  time of report (12:30 pm, May 1), albeit all adverse effects have improved somewhat
Nausea, headache,  severe muscular and joint aches, night sweats, weird dreams, golf ball size red circle at injection site warm to touch, itchy  with lump under skin.
achiness; water bowel movement; chills; nausea; fever; Dizziness; inability to sleep; inability to rest; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), INSOMNIA (inability to sleep), RESTLESSNESS (inability to rest), DIARRHOEA (diarrhea) and PAIN (achiness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Dizziness), INSOMNIA (inability to sleep), RESTLESSNESS (inability to rest), DIARRHOEA (diarrhea), PYREXIA (fever) and NAUSEA (nausea). On 26-Mar-2021, the patient experienced PAIN (achiness), BOWEL MOVEMENT IRREGULARITY (water bowel movement) and CHILLS (chills). On 24-Mar-2021, DIZZINESS (Dizziness) had resolved. On 26-Mar-2021, PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, INSOMNIA (inability to sleep), RESTLESSNESS (inability to rest), DIARRHOEA (diarrhea), PAIN (achiness), BOWEL MOVEMENT IRREGULARITY (water bowel movement) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 101 (High) 101 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non significant follow up received on 24MAY2021, included 2nd dose Moderna vaccine details and events
On 12/27/2000 the patient presented to the physician's office with 10-12 vesicles on his body. Subsequently, on 01/02/2001 the patient recovered. Additional information is not expected. Per F/U 6/17/02: There were no known allergies and no past medical history. The pt was vaccinated SC with a 1st dose of varicella. On 12/27/00, the pt "came down with chickenpox". Subsequently, on 1/2/01, the pt recovered. Additional info is not expected.
BRUISING ON BACK OF LEFT KNEE; SEVERE PAIN ON LEFT LEG BEHIND KNEE; HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced headache. On 26-APR-2021, the subject experienced bruising on back of left knee. On 26-APR-2021, the subject experienced severe pain on left leg behind knee. On 10-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and headache on 20-APR-2021, and had not recovered from severe pain on left leg behind knee, and bruising on back of left knee. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
No additional AE reported; HBP called to report that a dose of RECOMBIVAX HB was given after a TE.; This spontaneous report has been received from a consumer, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 24-JUL-2023, the patient was vaccinated by a health care professional with an improperly storage dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection, as prophylaxis (lot number: W038227, which was determined to be valid as vial formulation by the validation lot team, with an expiration date on 23-MAY-2025) (strength, dose, scheme, route and anatomical location of administration were not reported (Product storage error).  The administered dose underwent a temperature excursion above 47 degrees Fahrenheit (F) (63.5F) for 7 hours. No previous temperature excursion was reported.  No additional adverse event was reported.
constant non consolable crying for more than 3 hrs immun given about 8AM; phone call from babysitter 1145AM & could hear pt crying in back ground; pt taken to ER given med to make sleep; advised from ER MD to get 1/2 dose  w/next DTP;
upon initial injection,  pins and needles down left arm.  Immediate onset of high blood pressure.  Few hours later developed typical "flu like symptoms".  Next day woke up and both arms, hands, legs and feet and side of face had pins and needles and felt numb. Heart rate sky rocketed and went to ER. Felt like I was going to pass out.  Took blood work at hospital and doctors reassured that the feeling should come back in my legs and arms. When I left  6 hours later my legs were still pins and needles and my joints began to hurt.  A week later and this feeling continues to come and go, but is not consistent.  My joints still randomly hurt and I am an active 38 year old with three kids.
39 year old male received anthrax #1 on 26 Jul 04.  He experienced pain and erythema at the injection site immediately after injection.  The erythema eventually extended from the deltoid to the shoulder and was confluent, without any raised areas.  Approximately 4 hours after receipt of the vaccine, he had generalized pruritus that he treated with oral Benadryl.  The erythema resolved within a few days, but the pain in the left arm continued with tingling in the arm down to the 4th and 5th digits of the left hand.  This pain is constant and has not responded to ibuprofen 800 mg.  He denies upper extremity weakness and this does not impair his ability to perform his job.  He does report aching and weakness in his thigh bilaterally.  He denies any history of similar symptoms.
Low grade fever (99.8 F), chills, fatigue, headache, sleep disturbance, loss of appetite
Pt recvd vax on 17MAY92, 16APR92 & 21SEP92 & 5OCT92 pt devel herpes zoster, stated that rt side of head was first affected & it spread to rt eye causing it to shut; treated w/meds;