chrisvoncsefalvay/vaers-outcomes huggingface dataset:
entire left shoulder area was swelling; like having "poison ivy"; red shoulder area; uncomfortable; tchy rash; difficulty sleeping; chills; sore left arm; feeling sluggish; difficulty focusing; pain at the injection site; a red circle at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), SWELLING (entire left shoulder area was swelling), VISION BLURRED (difficulty focusing), INSOMNIA (difficulty sleeping) and SLUGGISHNESS (feeling sluggish) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication:  1292263 (she was in a clinical trial with  for their COVID-19 vaccine) and FLU VACCINE VII (flu vaccine anually). Concurrent medical conditions included Rosacea. Concomitant products included SPIRONOLACTONE for Rosacea, VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), VISION BLURRED (difficulty focusing), SLUGGISHNESS (feeling sluggish), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (a red circle at the injection site) and HEADACHE (headache). On 03-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping) and CHILLS (chills). On 04-Mar-2021, the patient experienced SWELLING (entire left shoulder area was swelling), RASH PAPULAR (like having "poison ivy"), ERYTHEMA (red shoulder area) and RASH (tchy rash). On an unknown date, the patient experienced MALAISE (uncomfortable). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore left arm), SWELLING (entire left shoulder area was swelling), VISION BLURRED (difficulty focusing), INSOMNIA (difficulty sleeping), SLUGGISHNESS (feeling sluggish), RASH PAPULAR (like having "poison ivy"), ERYTHEMA (red shoulder area), RASH (tchy rash), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (a red circle at the injection site), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used Ice on her arm for treatment.
4/4/21 facial weakness, unable to close eye. Primary care physician diagnosed Bells Palsy 29 days after COVID vaccine 2nd dose on 3/6/21.
Patient fainted about 15 minutes after receiving Janssen Covid-19 vaccine. She lost consciousness for about 3-5 minutes. She continued to breath and was not cyanotic. After 3-5 minutes she regained consciousness. She reported that she had experienced this before with injections. I had her remain in the pharmacy for an additional 30 minutes and checked her blood pressure twice. The second BP check was at 2:05pm and her BP was 108/68. The patient left the pharmacy at 2:05pm.
10 days-following vaccination, patient became ill with encephalitic like syndrome requiring ventilation and ICU care. AbnL MRI, neg. Viral studies. See attached records. Follow up received on JAN 11 2010 - Onset; Day of admission. The onset of illness documented in the faxed records from hospital where child was initially taken with stupor and ataxia, and subsequently transferred to Childrens Hosp. Medical Center the same day.
Developed pain, numbness and swelling at the injection site left deltoid area. Treatment Ice pack, Loratadine 1 stat.
12hr p/vax tenderness in lt axilla;24hr p/vax lt axillary lymph glands tender, very swollen lasted 12-18hr;
just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; myalgia; fever; Pain in my hips affected my ability to walk/gait; Pain was 8/10, constant, achy and throbbing; This is a spontaneous report from a contactable physician.  A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685 expiration date unknown), intramuscularly, on an unspecified date in  Dec2020 at 17:00 (at the age of 32-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient did not have any allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Just shy of twenty-four hours after receiving the vaccine,  the patient developed bone/ joint pain in hips and shoulders, myalgias, a fever and pain in her hips which affected her ability to walk/gait. Her pain was 8/10, constant, achy and throbbing. Movement and sitting in the same position exacerbated the symptoms. The patient specified that she did not receive any treatment for the events. She did mention, however, that a hot shower and sleep eased her symptoms.  The clinical outcome of bone pain, joint pain, myalgia, fever, pain and difficulty in walking was reported as self-limited and resolved completely within 12-14 hours. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Large red, hard bump at area os inoculation. (Pain associated with bump). Large bump still present 7 days later (appears bruised).
"not feeling well"; her rapid heart rate was from anxiety; "uncomfortable headache"; "rapid heartbeat" /"rapid heartbeat on and off" /"continued rapid heart beat that lasted two weeks"; "not being able to sleep with a caffeine feeling"; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS ("rapid heartbeat" /"rapid heartbeat on and off" /"continued rapid heart beat that lasted two weeks"), INSOMNIA ("not being able to sleep with a caffeine feeling"), MALAISE ("not feeling well"), ANXIETY (her rapid heart rate was from anxiety) and HEADACHE ("uncomfortable headache") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information history reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PALPITATIONS ("rapid heartbeat" /"rapid heartbeat on and off" /"continued rapid heart beat that lasted two weeks") and INSOMNIA ("not being able to sleep with a caffeine feeling"). On 28-Feb-2021, the patient experienced HEADACHE ("uncomfortable headache"). On 08-Mar-2021, the patient experienced ANXIETY (her rapid heart rate was from anxiety). On 09-Mar-2021, the patient experienced MALAISE ("not feeling well"). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PALPITATIONS ("rapid heartbeat" /"rapid heartbeat on and off" /"continued rapid heart beat that lasted two weeks"), INSOMNIA ("not being able to sleep with a caffeine feeling"), MALAISE ("not feeling well"), ANXIETY (her rapid heart rate was from anxiety) and HEADACHE ("uncomfortable headache") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood test: normal (normal) normal. On 09-Mar-2021, Chest X-ray: normal (normal) normal. On 09-Mar-2021, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient spent six hours in the emergency department and she has been asymptomatic ever since after being discharged.
Joint pain that would travel from one part of the body to another (groin area, left knee, right knee, right hand, etc). It would stay in one place for a few days before moving to the next area.
Developed pain left shoulder 3-4 hours after receiving flu shot. Tried 5 day course of PREDNISONE with temp relief - pain returned with limited abduction.
pt recv vax 10NOV95 & 11NOV95 pt exp swelling 6cm away from inj site;pt to MD dx cellulitis;reporter noted that MD was not told that the pt had recv vax;
pt given vaccine. within 10 minutes looked clammy. fell asleep snored woke up eyes rolled. emt happened to be in store he asked to lay down  was laid down emt elected to have him go to hospital for evaluation
HYPOTENSION 3/3/2022 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION
Patient is a 95y/o female followed at Oncology by Dr. for evaluation and management of her breast cancer, now treating with Fulvestrant/ Ogivar, last received on 6/3/22.  The patient was undergoing workup for a transaortic valve repair and had CT angiography of chest, abdomen, and pelvis done at hospital on May 28, 2020. She was found, incidentally, to have an asymmetric left breast density, and enlarged left axillary lymph node, which were indeterminate for malignancy. She underwent mammogram on 6/10/2020 and was found to have a hypoechoic solid mass measuring 25 mm in the left axilla along with a focal asymmetry measuring 4.4 cm in the left breast at the 7 o'clock position. Biopsy was done on 6/11/2020 and the biopsy confirmed an infiltrating ductal carcinoma, grade II, in the primary breast mass, as well as a positive left axillary node. The tumor was ER positive at 66%, PR weakly positive at 2%, Ki­67 was 36%, and HER2 was positive at 3+.  The patient was evaluated by Dr. (breast surgeon). Because she is so close to her valve replacement and is on Plavix, it was not recommended that she undergo surgery upfront.  Diagnosed in 20 She had a rectal prolapse repair by Dr. on 5/2/22 and has recovered from that well.   She presented to clinic today with fever, chills and a septic looking picture.  Blood cultures/ UA were obtained and plans for admission made.  She was incidentally found to be COVID positive. Case discussed with Dr.  OK to go to the floor, negative pressure room  Hold antivirals at this time as we are unsure when she became positive.  Admitted to hospital on 06/17/2022, currently (6/22/22) in hospital.
RIGHT HAND MIDDLE FINGER TURNING BLUE/PURPLE; 3 LITTLE ROUND DOTS/SPOTS OF BLOOD AROUND SITE OF INJECTION; LOST ALL CIRCULATION IN FINGER; TINGLING AND NUMBNESS IN RIGHT HAND MIDDLE FINGER; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: bad fall, and concurrent conditions included: high blood pressure, low thyroid, penicillin allergy, latex allergy, allergy to sulfate drugs, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient have no drug abuse or illicit drug usage. The patient takes anti-hypertensive medication to prevent stroke, no history of stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced right hand middle finger turning blue/purple. On 06-AUG-2021, the patient experienced 3 little round dots/spots of blood around site of injection. On 06-AUG-2021, the patient experienced lost all circulation in finger. On 06-AUG-2021, the patient experienced tingling and numbness in right hand middle finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand middle finger turning blue/purple, lost all circulation in finger, and tingling and numbness in right hand middle finger on 09-AUG-2021, and 3 little round dots/spots of blood around site of injection on 20-AUG-2021. This report was non-serious.
Report noticed red ithchy rash in palms of both hands and soles of both feet 48 hours after receiving Tdap vaccine.
This case was reported by a healthcare professional and described a subject of unspecified age and gender who did not respond to immunization with Twinrix for prophylaxis. On an unspecified date on or before 07 November 2006, the subject received unspecified dose of Twinrix. At an unspecified time after vaccination with Twinrix, on an unspecified date on or before 07 November 2006, serology tests for hepatitis A antibody and hepatitis B surface antibody were negative.
two lumps noted on lt anterior thigh in inj area;1 approx 3cm & other approx 1 cm in size;tenderness noted on palpation;mom stated pt acted like leg was sore;mom told lumps would gradually go away;
Fever, rigors, severe nausea, headache, generalized weakness, body and joint aches. These lasted 10 hours. Total 4 days of significant fatigue, joint aches, neck stiffness.
information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is complained and alleged that that the patient was inoculated with a dose of ZOSTAVAX on or about 09-OCT-2012 at a health facility as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-DEC-2012, the patient was treated at a health care facility for a painful rash diagnosed as shingles. On or about 10-JAN-2013 the patient was treated at a medical facility for ongoing shingles outbreaks. While shingles is an incurable condition, the patient was prescribed acyclovir  (manufacturer unknown) and valacyclovir (VALTREX) to manage his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Additional information has been requested.
burning pain down left leg to calf which still hurts when he lays down; Cannot sleep; Tossing turning to get comfortable; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (burning pain down left leg to calf which still hurts when he lays down), INSOMNIA (Cannot sleep), RESTLESSNESS (Tossing turning to get comfortable) and ARTHRALGIA (hip pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis, Hypertension, Diabetes mellitus and Arthritis. Concomitant products included BISACODYL (DULCOLAX [BISACODYL]), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYDROCHLOROTHIAZIDE + LOSARTAN), MELOXICAM, ACETAMINOPHEN, DULOXETINE, METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MAGNESIUM, GABAPENTIN and ATORVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (burning pain down left leg to calf which still hurts when he lays down), INSOMNIA (Cannot sleep), RESTLESSNESS (Tossing turning to get comfortable) and ARTHRALGIA (hip pain). At the time of the report, PAIN (burning pain down left leg to calf which still hurts when he lays down), INSOMNIA (Cannot sleep), RESTLESSNESS (Tossing turning to get comfortable) and ARTHRALGIA (hip pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
The patient was administered an improperly stored dose; This spontaneous report as received from a Licensed practical nurse reporting about a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.      On 21-APR-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S004548, expiration date: 12-AUG-2020 (dose number, route of administration and anatomical location were not reported) for prophylaxis. This dose was improperly stored at a temperature of 47.3-degree Fahrenheit for a time frame of 20 minutes and discovered due to a digital data logger. No previous temperature excursions occurred. This is one of several cases from the same source. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302:
Pressure behind left ear causing dizziness/lightheadedness. The pressure is accompanied with occasional ringing in the left ear, sometimes very loud ringing.
I had just been lot of breathlessness in the morning; I am feeling some of the symptoms on the paper; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "I had just been lot of breathlessness in the morning"; MALAISE (non-serious), outcome "unknown", described as "I am feeling some of the symptoms on the paper".  Additional information: Patient wanted to known he had his first vaccine shot (Covid-19 Vaccine) the other day and I had just been lot of breathlessness in the morning and the papers they email you said to contact for anything like that." Later patient hung up the call abruptly. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient notified immunizer that she has a personal and family history of experiencing seizures after receiving vaccinations. She received the COVID Pfizer bivalent booster first, and then after the flu vaccine she experienced a mild seizure. Patient was sitting in a chair at the time, and we had a nurse immunizer as well, who was monitoring the patient (noted that patient's skin felt clammy). Patient sat for an extended period of time, and then was picked up by a family member. No other signs or symptoms to report.
The patient is a 49 year old male who has a past medical history significant for bipolar disorder with manic episodes, OSA on CPAP, morbid obesity, HLD, and  relapsing remitting MS.  Per chart review, patient's MS was initially diagnosed in 2012 on MRI and LP and was on Copaxone for several years but stopped taking in 2017.  Symptoms and imaging remained stable through 2019 then patient was lost to follow up until he was seen by Dr.  on 4/12/21 who ordered an outpt MRI.   Patient had COVID vaccine with Jansen vaccine on 4/10/21.  He developed bilateral upper and lower exremity weakness and urinary retention on 4/21/21 which prompted presentation.  He came into ED 4/21/21 and had foley placed but removed foley and decided to leave AMA. Returned on 4/22/21 with worsening symptoms and was subsequently admitted. Patient was seen by neurology and started on high dose steroid x5d for MS exacerbation. Initial MRI of the brain obtained on 4/22/21 was notably stable without change in previously described white matter disease. No new lesions to suggest active demyelination. New plaques were noted on MRI C and T spine (4/22/21). It is noted that patient received COVID19 vaccination with J&J vaccine on 4/10/21 and temporal relationship between his acute presentation and recent vaccination was questioned.    On 4/30/21, patient developed severe bilateral facial weakness and he additionally was reported to have had an episode of aspiration.  Repeat MRI brain on 4/30/21 showed new bilateral facial nerve enhancement. Etiologies could include: GBS, Lyme disease, botulism, neurosarcoidosis, less likely myasthenia gravis.  LP was pursued on 5/1/21 which was significant for tube 4 with 136 WBC, 88% lymphocytes, glucose 89, protein 632. Meningitis/encephalitis panel was negative.  Lyme CSF was negative, Lyme antibody panel was positive.  MuSK antibody negative.  ACE blood level normal.  Ganglioside antibody panel and myasthenia graivs adult panel pending. He is being treated for Lyme disease with Ceftriaxone 2g IV daily since 5/1/21 with plan for 2-4 week course to cover for Lyme disease.  He is still admitted and is still having symptoms of facial palsy as of today (5/4/21)
Information has been received from a registered nurse concerning a 6 year old white male with no past medical history on 23JUL1998 was vaccinated with a first dose of varicella virus vaccine live, in the right arm. Concomitant therapy that day included a third dose of hepatitis b virus vaccine rHBsAg, in the left arm. There was no illness at the time of vaccination. Between 26DEC2003 and 30DEC2003 the pt developed "red spots and some fluid filled." On 30DEC2003, the pt developed 20 scattered scabs on face, trunk, extremities. The pt sought medical attention and was treated symptomatically. There were no relevant diagnostic or laboratory tests performed. The pt recovered. It was reported that the pt did not have any adverse events following prior vaccinations. It was noted that the pt on 24OCT1998 received a fourth dose of Hib conj vaccine, in the right arm, and a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live, in the left arm. It was also reported that on 24APR1998 the pt had a Mantoux test. No further information is expected.
Subsequent to receiving one dose of varicella virus vaccine live, the pt developed a rash. Follow up states no further information is available.
Second day spent sleeping nearly the whole day. I On the left arm, injection site is a red rash.
Very high fever (I think), sweating (lost 4 lbs of 123), nausea, passed out.   Husband found me on the ground (just a short time),  shook me, and I responded.    Went to bed, stayed in bed the next day.
Received vaccines on 3-24-05- on 4-2-05 child broke out with hives from head to toe- Immediately placed on Benadryl by parent- when Benadryl was not given exactly at every 4 hours child continued to break out with additional hives, 2nd break out child had hives on back, stomach. 3rd break out (5 1/2 hrs after last dose of Benadryl) hives had covered body-taken temp on 4-4-05, dx as viral illness
Headache dry mouth and flushed Narrative:  Employee stated after receiving 2nd vaccine began to have severe headache not relieved with Tylenol, flushed, and dry mouth