chrisvoncsefalvay/vaers-outcomes huggingface dataset:
today seriously sick; feels down; Hasn´t eat anything; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (today seriously sick), DEPRESSED MOOD (feels down), DECREASED APPETITE (Hasn´t eat anything) and NAUSEA (Nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Dialysis (Patient is on dialysis) since an unknown date.On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced MALAISE (today seriously sick), DEPRESSED MOOD (feels down), DECREASED APPETITE (Hasn´t eat anything) and NAUSEA (Nauseous). At the time of the report, MALAISE (today seriously sick), DEPRESSED MOOD (feels down), DECREASED APPETITE (Hasn´t eat anything) and NAUSEA (Nauseous) outcome was unknown. No concomitant medication was reported.No treatment medication was reported. Company comment- This case concerns a male patient, unknown age, with medical history of undergoing dialysis, who experienced the non-serious, unexpected events of malaise, depressed mood, decreased appetite and non-serious expected event of nausea. The events occurred  one day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. Sender's Comments: This case concerns a male patient, unknown age, with medical history of undergoing dialysis, who experienced the non-serious, unexpected events of malaise, depressed mood, decreased appetite and non-serious expected event of nausea. The events occurred  one day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
SORE THROAT; LITTLE COUGH; SOME CONGESTION; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and cigarette smoker, and other pre-existing medical conditions included: Patient had no known drug allergies or no 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced sore throat. On 01-SEP-2021, the patient experienced little cough. On 01-SEP-2021, the patient experienced some congestion. On 02-SEP-2021, Laboratory data included: COVID-19 virus test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, little cough and some congestion was not reported. This report was non-serious.
severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-occipital; severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-occipital; severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-occipital; This is a spontaneous report from a contactable consumer reporting for herself. A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 07Apr2021 at 08:00 (Batch/Lot Number: EP7533) (at the age of 47 years old) as a single dose  for COVID-19 immunisation.  The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6204) (at the age of 47 years old) as a single dose  for COVID-19 immunisation. Medical history included factor v deficiency from an unknown date and unknown if ongoing, protein c deficiency from an unknown date and unknown if ongoing. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR) taken for an unspecified indication, start and stop date were not reported; ibuprofen taken for an unspecified indication, start and stop date were not reported; diclofenac potassium (VOLTAREN ACTI) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021 at 14:00, the patient experienced severe pain when breathing which resulted in bilateral pulmonary embolisms, deep vein thrombosis (DVT) in right calf, non-occipital. The events severe pain when breathing which resulted in bilateral pulmonary embolisms, deep vein thrombosis (DVT) in right calf, non-occipital required a physician's office visit, emergency room visit and hospitalization for 1 day. The outcome of the events severe pain when breathing which resulted in bilateral pulmonary embolisms, deep vein thrombosis (DVT) in right calf, non-occipital was recovered in Apr2021. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up needed, further information has been requested.
Left thigh with large swollen red area and warm to touch.  Seen by Dr and prescribed Keflex for treatment.
received a dose of Arexvy without reconstitution (liquid portion only); received a dose of Arexvy without reconstitution (liquid portion only); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 85-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: received a dose of Arexvy without reconstitution (liquid portion only)) and inappropriate dose of vaccine administered (Verbatim: received a dose of Arexvy without reconstitution (liquid portion only)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The pharmacist reported that patient might had received a dose of Arexvy without reconstitution (liquid portion only), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was not in the office, did not provide further information. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow-up.
Hospitalized 9/21/2021; COVID-19 positive 9/21/2021; fully vaccinated  HOSPITAL COURSE: Patient is a 77 year old woman who was admitted to hospital on 9/22/21 after presenting with poor po intake, shortness of breath, fever, chills and cough. She was found to have COVID-19 viral pneumonia and was suspected to have secondary bacterial infection as well. Family reported a recent increase in lower extremity edema. Labs showed a grossly elevated BNP. She was started on empiric abx. She was not hypoxic and therefore did not get steroids/Remdesivir for COVID.    An echo was ordered and unfortunately showed significant changes. EF was only 20% and there was severe valvular heart disease. The etiology for her reduced ef could be ischemic but patient/family did not want to pursue additional work up. Patient would not take food and was consistently hypoglycemic. We had a lengthy goals of care discussion and ultimately they wanted to pursue hospice care. The plan is for her to go home with hospice care and potentially transition to the home health next week.    At this time, Patient is not hypoxic. She is taking a diuretic but is not on bb or ace-I due to relatively low blood pressures. We attempted Marinol to improve po intake but this did not seem to help.
I was sick for 3 days with fever, headache, and fatigue. Now 12/24/2021 rash on my body, very itchy and burns. Shows up on different parts of my body.
Extreme dizziness out of the blue on day 4. Numbness/tingling in left hand up to elbow, and the pinky and next finger. Left knee numbness, especially if sleeping on the left side. Right foot, calf pain, cramping that sometimes go up the thigh. Continued dizziness and 4 weeks of severe indigestion.
day after vaccination suffered from a massive cerebellar stroke with ischemic infarct and suspected embolic stroke required emergency craniectomy with cerebellar resection
1st dose of SHINGRIX in left deltoid 3/20/2019 3:50pm - patient stayed for 15-20 minutes, noticed tingling across shoulders (both sides) after a few minutes of receiving the vaccination. Advised patient to sit and inquired about any chest pain or heaviness, any shortness or breath or any lightheadedness/dizziness. He denied any and said the tingling was not severe. We continued to monitor him for the 20 minutes following the vaccination and he denied any worsening or new symptoms. The tingling had resolved before he left. Followed up 3/20/2019 5:50pm via phone and he had not had any issues since he left. Said he felt completely fine.
Admitted with severe Hypoxic status in Feb. Said to have COVID Jan 27 hospitalized then until 2/4. Then returned with worsened symptoms and admit 2/16/22.
Patient received 2nd dose of 2 dose series of Bexsero on 1/30/23. Error in rx processing at pharmacy caused omission of vaccine report to agency. Patient received an additional dose of Bexsero at MD office at appt on 2/24/23.
Within 8 hours pain and slight swelling in right upper arm., pain increasing thru the night.   About 24 hours after the injection,  I had severe lethargy and headache.  These symptoms did not begin to subside for 72 hours.    My right arm is still tender to the touch, warm and sore.
Pt. recieved Varicella Vaccination 09/09/03. Returned to clinic 09/25/03 with Puritic macular rash covering scalp,chest,back, arms and hands. Described as "itchy". Onset 09/22/03.
Heat in my chest; Achiness in my chest; Pain in my arm; Achiness; Little bit of a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (Heat in my chest), CHEST PAIN (Achiness in my chest), PAIN IN EXTREMITY (Pain in my arm), MYALGIA (Achiness) and PYREXIA (Little bit of a fever) in a 65-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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced CHEST DISCOMFORT (Heat in my chest), CHEST PAIN (Achiness in my chest), PAIN IN EXTREMITY (Pain in my arm), MYALGIA (Achiness) and PYREXIA (Little bit of a fever). At the time of the report, CHEST DISCOMFORT (Heat in my chest), CHEST PAIN (Achiness in my chest), PAIN IN EXTREMITY (Pain in my arm), MYALGIA (Achiness) and PYREXIA (Little bit of a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-405046, MOD-2021-405481 (Patient Link).
Approximately 4 days after the Hepatitis A shot my left arm started to itch where th shot was given. I started rubbing it and it became very itchy and red. Inj doctor said to use ice on it 24 hrs, and take an Ibuprofen it was cleared up.
Less than 24 hours after administration, she cried and screamed for more than 6 hours and continued to scream and cry off and on for the next several days.  She also ran a high fever, and we gave her tylenol.  She was a different baby during this time.  She had blank stares and did not smile for days.  We do not know if she was permanently damaged in any way.
Information has been received from an investigator concerning a 35 year old female with no known drug allergies, with HIV and alcohol use who entered a study. On 16-JUL-2008 the patient was vaccinated with the first dose of GARDASIL 0.5 mL via injection. On 11-SEP-2008, she was vaccinated with the second dose of GARDASIL 0.5 mL via injection and the third dose of GARDASIL was administered on 12-JAN-2009. Concomitant therapy included Kaletra, Truvada and Loestrin. Approximate duration of use of concomitant medications was reported as 2 months. On 09-APR-2009, the patient presented to the clinic for a non-study visit with complaints of feeling a lump on her right breast for three weeks. Upon evaluation by provider, the subject was referred for a mammogram for diagnosis. The mammogram was performed on 16-APR-2009 and revealed an abnormality in the right breast that was highly suspicious for ductal carcinoma in situ. On 20-APR-2009 the patient was seen for the right breast lump and right breast tenderness. There was no nipple discharge, no axillary nodes of skin changes were noted. There was no family history of breast cancer. A biopsy was recommended by clinic provider. The biopsy was performed on 04-MAY-2009. On 07-MAY-2009 the patient received pathology results from the breast biopsy that confirmed the lump was ductal carcinoma in situ (grade 4). The patient was scheduled to visit with specialist to explore treatment options on 12-MAY-2009. Follow-up information was received in a pathology report. The patient had 1x1 cm palpable mass. On 04-MAY-2009, a right breast core needle biopsy was performed and ductal carcinoma in situ, high grade) was diagnosed. The patient's ductal carcinoma in situ (grade 4) persisted. The reporting investigator classified the event of ductal carcinoma in situ (grade 4) as possibly related to study therapy with GARDASIL. The patient's ductal carcinoma in situ (grade 4) was considered to be an other important medical event. Additional information is expected.
Patient fainted (loss consciousness) a couple of minutes after receiving injection. Mom caught him and called for help and reported his eyeballs rolled up and he started down when she caught him. by time Pharmacist and store staff got there (less than a minute) he had regained consciousness but very lightheaded. No breathing difficulty. So got a chair and had him sit with head down and store staff observing. After another 10min he still reported lightheaded and nausea, so ambulance was called. When they arrived and checked him out everything checked out normal and he was feeling better so they released him to his parents care. Called on 5/24/21 at 10:10am and spoke to mom who reported he was doing fine and no apparent after effects.
difficulty with both grips (but more in right); feet feel like there are pins and needles and she does not always know where they are; intermittent pain in calves and feet and in knees, hips, wrists, and ankles; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Apr2021 10:15 (Lot number: EL9261) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Preglaucoma" (unspecified if ongoing); "Drug allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: CLONAZEPAM; ESCITALOPRAM. Vaccination history included: Bnt162b2 (Lot number=ER8732,, administrator route=Intramuscular,, administration date=27Mar2021,, administration time=10:15 AM,, dose number=1,, vaccine location=Right arm}]), administration date: 27Mar2021, when the patient was 41 years old, for COVID-19 immunisation, reaction(s): "pain", "Fever", "weakness", "Throat tightness", "Myalgia", "Arthralgia", "Skin pain", "Muscular weakness". The following information was reported: GRIP STRENGTH DECREASED (non-serious), outcome "not recovered", described as "difficulty with both grips (but more in right)"; PARAESTHESIA (non-serious), outcome "not recovered", described as "feet feel like there are pins and needles and she does not always know where they are"; PAIN (non-serious), outcome "not recovered", described as "intermittent pain in calves and feet and in knees, hips, wrists, and ankles". The events "difficulty with both grips (but more in right)", "feet feel like there are pins and needles and she does not always know where they are" and "intermittent pain in calves and feet and in knees, hips, wrists, and ankles" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of grip strength decreased, paraesthesia, pain.  Additional information: Once she had second shot, difficulty with both grips (but more in right). Her feet feel like there are pins and needles and she does not always know where they were. She had intermittent pain in calves and feet and in knees, hips, wrists, and ankles. No other vaccine in four weeks. No Covid prior to vaccination.  Follow-up attempts are completed. No further information is expected.
Low grade fever x 2 days: onset 3 days after immunization then 15 days after, pt developed vesicle on leg,a anus and 5-6 more lesions on body x 2d with low grade fever of 99. By the 19th d post vaccination itchy pinpoint vesicles erupted all over chest/back over 2 days, rash pruritic, skin rough; all lesions scabbed by 22nd day post vaccination. Pt was not seen here, but was see by mother's family practitioner who diagnosed pt with classic chickenpox.
Started feeling sick to stomach and fever around 9:30 a.m. on 3/12/2021.  Fever stayed from 100.4 to 102.8 until 3/14/2021 around 3:30 a.m.  Very swollen around left arm and around left side of neck with a swollen knot at my collar bone and it is bruised.  Arm, neck, and collar bone area on left side still sore but not as bad as it was.  I got thrush in my mouth and I noticed it on 3/14/2021 (Morning 7:00 a.m.).
C/O Chest pain on 3/22 and 3/23, pain went through chest area and then went away.  Did this Approx. 3 times in 30 minute time period.  No other c/o voiced at that time.
This case was received from a health professional on 07 November 2008, and represents a cluster of 20 patients. Twenty patients, all employees of a health care facility, reported experiencing adverse reactions after receiving intramuscular injections of FLUZONE SV 2008-2009 (lot number U2762AA). Following vaccination, one female patient "self diagnosed herself with ocular respiratory syndrome". One female patient complained of pain in the vaccinated arm, with ongoing difficulty lifting the arm. Two patients complained of itch and hives. Eleven patients had body aches, chills, and fever six to twelve hours after vaccination; seven of those eleven patients missed one day of work. Five patients reported pain at the injection site, radiating to the neck and down to the fingers. Individual identifiers were not provided, and outcome was unknown. Follow-up information was received from the health care professional on 13 January 2009, and provided patient identifiers for each of the patients reported in the original case. This case now pertains only to a female patient who complained of both arms "itching profoundly" on 14 October 2008 (date of vaccination not reported). Treatment included CLARITIN and hydrocortisone. Outcome was not reported. Follow-up information received on 13 February 2009 from a health care professional. The patient had been vaccinated with a prior dose of flu vaccine (Trade name, manufacturer name, route and site not provided) in 2002 and experienced a rash and itch. The patient was 46-years-old at the time of vaccination with FLUZONE SV 2008-2009 on 14 October 2008. The FLUZONE was administered in the deltoid. The patient recovered; however a recovery date was not provided. No further information is expected. Follow up information received on 20 April 2009 from a health care professional. Based upon new information, this case meets seriousness criteria and has been upgraded to serious. On 14 October 2008, the patient medicated with PEPCID and Prednisone prior to administration of FLUZONE SV 2008-2009 which was administered in the right deltoid, indication not reported. Within hours, the patient developed a rash from head to toe and had to leave work. The patient went to the doctor's office and was prescribed a SOLUMEDROL dose pack, PEPCID, and BENADRYL. The rash lasted for two days and the patient made a full recovery. The patient was instructed to avoid future flu vaccinations. This patient is one of a cluster of 20 patients. The other 19 patients are captured in case numbers 2009-00153 through 2009-00171, and case. The patient also has another adverse event that is reported in case 2009-00681. Documents held by sender: None.
TESTED FOR COVID ON 10-26-22, DECEASED 11-13-22.  hE HAD BEEN WEAK FOR A FEW DAYS AND HAD FOLEY WITH DECREASED URINE OUTPUT, SLIGHT ANEMIA, DEHYDRATION, CREATININE 3.4,  FOUND UNRESPONSIVE WITH LARGE AMT OF COFFEE GROUND EMESIS.   TRANSFERRED TO ICU.   CODE BLUE WITH ROSC TWICE BUT WENT ASYSTOLE.   PASSED AWAY ON 11-13-22.
Mouth sores/ulcers, sore throat, severe headache, fever, chills, sweating, rash over all major lymph node areas on the body, face rash, swollen throat, fatigue, cough and chest heaviness I experienced during Covid back in November has suddenly returned, aches
LOW GRADE FEVER. FLU LIKE SYMPTOMS. ACHES. CHILLS.
I began to have difficulty breathing, my pressure went up and I felt arrhythmias, the symptoms began to decrease around 1 am after I took medicine to calm the pressure
After the second dose of the vaccine my arm swelled up again, but it was worse and lasted longer. It started the day after vaccination. It was hot to the touch, and really tender. I had night sweats for three days after also. I just left it alone and it took six days for the swelling to go down. It was itchy after that point. It is still tender at the injection site after six weeks and there is a little red bump. Seven days after my first shot my arm started to swell. It started with an itch and then became swollen. It lasted six days before the swelling went down. I went to a clinic on the advice of my doctor and they gave me 10 days of Penicillin.
17MAY92 fever, h/a, sore throat, arthralgia, fatigue; photophobia; maculopapular rash 19MAY92;
1/22/21 - right after shot-headache, lightheaded, fatigue, muscle weakness, chills, joint and muscle aches, chills, nasal congestion, pain at shot site. Except for pain at shot site, lasted 24 hours  2/1/21- Developed feeling of anxiety, muscle spasms in arms and legs, sleeplessness, headache, lightheaded, joint and muscle pain, chills, sweats, continued pain in arm, itching, nasal congestion, low blood sugar. Symptoms began receding on second day with only itching and nasal congestion today 2/5  In the past, I have had similar reactions to some antibiotics, otc/herbal meds, flu shots. Was told by Allergist that these were not allergic reactions but side effects.
HEADACHES, ACHINESS, STINGING (NEUROPATHY) BODY ACHES, FOGGY HEADED, MEMORY ISSUES
Headache first day after injection, slight next AM, L arm muscle pain in whole arm by 10/31 lasting 3-4 days, bilateral leg pain by 11/2/2019 especially in groin area. Bilateral leg pain & mild weakness continuing. Persistent fatigue. All symptoms seem to be gradually, slowly resolving. Not seeking medical care/treatment.  Self care.
Extreme rash & itching   started Sept. 26, 2021.   Still going on daily.