chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LUMP UNDER THE SKIN CLOSE TO VACCINATION SITE; LUMP WAS GOING TO LOOK LIKE A BRUISE; SORE ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced lump under the skin close to vaccination site. On 20-MAY-2021, the subject experienced lump was going to look like a bruise. On 20-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from lump under the skin close to vaccination site, and the outcome of sore arm and lump was going to look like a bruise was not reported. This report was non-serious.
Initial report received from healthcare professional on 19 September 2014. A 61-year-old female patient, whose concomitant medications were not reported, had received first dose of FLUZONE QIV (batch number UI196AC in left deltoid and route of administration was not reported) having expiry date 30 June 2015 on 18 September 2014. The patient had osteoporosis and has no known allergies. The patient has no illness at the time of vaccination and did not receive any other vaccinations within four weeks of FLUZONE QIV vaccination. It was reported that on 18 September 2014, 25 minutes after receiving FLUZONE QIV vaccine, the patient experienced large 4 by 6 inch swelling with redness which was very itchy. The patient has applied ice immediately as a corrective treatment and has no laboratory investigations. At the time of this report, the outcome was unknown. The patient required ER/doctor visit. Documents held by sender: none.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 21-APR-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered shingles in ear, Bell's palsy, and Ramsay Hunt syndrome. As a direct and proximate result of defective ZOSTAVAX, patients symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, Bell's palsy and shingles in ear/Ramsay Hunt syndrome were determined significant medical event. Bell's palsy and shingles in ear/Ramsay Hunt syndrome were considered disabling. Additional information has been requested.
sore arm; zigzag lines in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and EYE DISORDER (zigzag lines in the left eye) in a 66-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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and EYE DISORDER (zigzag lines in the left eye). At the time of the report, VACCINATION SITE PAIN (sore arm) and EYE DISORDER (zigzag lines in the left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included a blood pressure pill, not otherwise specified. No treatment details reported.
pt recv vax; 24 hr later, devel full body rash & dec appetite; no hx of fever;seen in MD's ofc & dx w/ erythema multiforme minor;
Day after vaccine: low fever and lethargy that lasted for a day, swelling and pain at injection site that lasted a few days Week after:  reaction dubbed "COVID-arm", small patch of hardness and itching at injection site that is still ongoing at this time
I woke up the next day and I felt fine. I went to work. At about lunchtime, I started getting a headache and it started at the front of my head but then by the end of the day it was my whole entire head. I still could work. It was there and throbbing. I took Tylenol - every four to six hours. That didn't really help. From that point forward, it slowly got worse to the point where it hurt to open my eyes, I didn't like the light, and I was in tears. I couldn't see straight every day and every day it was worse. I finally went to the doctor on Saturday. 23rd. She gave me a Toradol shot.  I went to sleep after I got home and when I woke up the headache was finally gone.
Raised, red rash at the vaccination site eight days post-vaccination in three year old patient. Approximately 2.5 inches wide. No fever, itchiness, or pain.
patient fainted.  Patient said she fainted prior that day during blood work and we were warned that she may do so following vaccination.  Pharmacist administered vaccine, patient walked to waiting area and sat down.  A minute or so later knew she was going to faint and layed on the ground with knees up.  Pharmacist sat with patient while she recovered.  Patient refused emergency services on several occasions. After 15 minutes patient felt better and left store.
The patient had a sore arm as soon as she received the shot. A couple of hours later around 4 oclock, the arm felt like it had been injured. Very high level of pain associated with it. Patient could not move her arm at all. She felt like it was locked to her body. She went to bed and got chilly. Today, the arm arm still hurts and she feels like whatever was injected did not move from the arm. Then as time went on she felt like whatever was in the arm started to move into her body finally. She is able to move her arm only about half way up. Currently she feels like her arm and knee are starting to get stiff. She says that overall she does not feel like herself. Her stomach was bothering her this morning and she feels like shes recovering from a cold or stomach virus.
Reported redness, swelling and pain at injection site, diarrhea and light headedness1/5/21. Evaluated in ED and hospitalized for neurological symptoms that started 1/8/21.
Patient IS EMPLOYED AT THIS OFFICE AND GOT HER ANNUAL FLU SHOT. SHE REPORTED TO ME TODAY THAT ABOUT 3 HOURS AFTER THE INJECTION SHE STARTED TO HAVE TYPICAL SITE SORENESS AFTER A VACCINE BUT ALSO NOTED TROUBLE LIFTING HER ARM. STILL HAVING SHOOTING PAIN IN SHOULDER AREA WITH CERTAIN MOVEMENT AND HER SHOULDER HAS LOCKED WITH MOVEMENT.
Moderna COVID-19 Vaccine  Soreness, itching, redness in arm where vaccine was injected started about 7 days after receiving vaccine.
Patient complained of swelling and redness at the site of injection and fever for 12 hours that night.
Information has been received from a health professional concerning a 6 year old male who on 11-JUN-2007 was vaccinated SC on the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 657449/0597U). On 12-JUN-2007, the patient experienced rash on back, neck and arms and itchiness. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of injection site numbness in a 61-year-old female patient who received BOOSTRIX (batch number 7C73A, expiry date 25th August 2017). On 11th June 2016, the patient received the 1st dose of BOOSTRIX (intramuscular) 0.5 ml. On 11th June 2016, less than a day after receiving BOOSTRIX, the patient experienced injection site numbness and injection site tingling. On an unknown date, the outcome of the injection site numbness and injection site tingling were not recovered/not resolved. It was unknown if the reporter considered the injection site numbness and injection site tingling to be related to BOOSTRIX. Additional details were provided as follows: This case was not previously reported to anyone. At 9:30 am, the patient received BOOSTRIX in the left deltoid and experienced numbness and tingling at the injection site, which was radiating down her arm. The patient required emergency room visit. On 13th September 2016, the patient was last seen at the office to evaluate the left arm.
feeling dragging.; tiredness; This case was reported by a consumer and described the occurrence of laziness in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 24th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced laziness and tiredness. On an unknown date, the outcome of the laziness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the laziness and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced tiredness and feeling dragging. The reporter consented to follow up.
feeling achey for 1 day, then complete loss of memory, speech, incoherent, hospitalized for 4 days, then slowly thought and understanmding came back. all test came back normal, ecg, cat, etc.
Itching, 4.5 cm X 4.5 cm erythema and lump 9/16/09.
Fever of 101 persistant crying, uninterested  in breast feeding; suggested not giving DTP; suggested by MD to only receive DT;
Father stated that ~ 15 min after vaccines were given pt stated that his stomach was hurting then leaned forward, vomited, and then leaned back in his chair, passed out and upper body and arms started shaking (per father, shaking forcefully - not tremors, but father also admits everything happened so fast and he was scared so he isn't sure how to describe the shaking; when asked if it was like a seizure, dad says he thinks so but says legs were not shaking). Father ran to grab patient and caught him before pt could fall, pt did not hit head. Father called for help. No nurses or doctors were present during the actual event and did not witness whether pt was trembling or had a seizure; patient had already regained consciousness by the time nurses and doctors arrived a few seconds later. Pt appeared pale but was awake, alert, oriented x 3 and had normal neuro exam.
Stomach pains; She came down with a possible C.dif (Clostridium difficile) issue or possible UTI after her 1st dose; She came down with a possible C.dif (Clostridium difficile) issue or possible UTI after her 1st dose; This is a spontaneous report from a contactable consumer and from Pfizer sponsored program from a contactable consumer (patient's husband). A 90-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included neck pain from an unspecified date and clostridium difficile infection from 2020 (C-diff issue started a year ago in which it was the consequence of taking 5 different antibiotics). The patient's concomitant medications were not reported. The patient experienced she came down with a possible c.dif (clostridium difficile) issue or possible UTI after her 1st dose on Apr2021 and stomach pains on an unspecified date. Consumer was reporting for his 90 year old wife who received her 1st dose of the Pfizer COVID vaccine with him in the beginning of April. He mentioned that she came down with a possible C.dif (Clostridium difficile) issue or possible UTI after her 1st dose. She is supposed to get her 2nd dose tomorrow but was advised by her doctor not to get it yet in order for them to wait for the results of her urine sample. He is asking if there have been reports of these issues after getting vaccinated. He mentioned that the C-diff issue started a year ago in which it was the consequence of taking 5 different antibiotics due to a possible meningitis diagnosis because of very serious pains on her neck. The meningitis was later ruled out. He mentioned that she is taking vancomycin and ventil for her stomach pains. The patient underwent lab tests and procedures which included Urine sample: unknown results on an unspecified date. Therapeutic measures were taken as a result of stomach pains. Outcome of the events was unknown.   Information about batch/lot number has been requested.
HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injection no treatment no improvement.
She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-356679 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no relevant medical history, who experienced the unexpected event of Thrombosis. The event occurred approximately 2 weeks after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report
Patient expired due to Large Bowel Obstruction.  (found to be COVID positive)    Attestation signed by MD at 8/7/2021 11:02 PM (Updated) General Surgery   Pt seen and examined on 8/6/2021 with the surgery team, all labs, vitals, imaging and objective data reviewed. Agree with the below note with the following addendum:   The patient is a 75-year-old female with multiple chronic medical comorbidities presenting to the emergency department with a complaint of abdominal pain.  She states that her pain just started this morning and really worsened around noon.  Has been rapidly worsening since that time.  She also notes significant nausea and abdominal distention.   She reportedly underwent colonoscopy several years ago which was incomplete due to inability to pass the colonoscope.  She reports that for the last several months the caliber of her stools has been very small.   AAOx3.  Writhing in pain.   No focal Neuro-deficits Non-labored respirations.   Very distended, severely ttp throughout Moving all extremities   A/P: 75 year old female with large bowel obstruction -large bowel obstruction:  The patient's CT scan and history are consistent with a diagnosis of large bowel obstruction.  She has evidence of severe dilation of all proximal colon.  The etiology of her obstruction is unclear.  It could be related to malignancy or, based on her history, it is more likely related to chronic diverticular inflammation.  Regardless of its etiology the patient is in distress and I am concerned that she is at high risk for colon ischemia or perforation.  She will need emergent operative exploration.  I discussed this case with the Dr with the colorectal surgery service.  Following our discussion the decision is made that the general surgery service should take the patient to the operating room.  I discussed the plan for operative intervention with the patient as well as her daughter.  I will plan for an exploratory laparotomy with sigmoid colectomy.  Risks of the surgery are significant.  We discussed the risks which include bleeding, infection, need for reoperation, need for multiple operations, cardiopulmonary complications from anesthesia, ostomy creation which may be temporary or permanent, hernia, and need for postoperative ventilator support.  The patient voices understanding of these and is eager to proceed with surgery. -COVID positive:  The patient has already had COVID and has since been vaccinated.  She is PCR positive for COVID today.  I will take respiratory precautions.  Is unclear whether this is an active COVID infection or not. -Coagulopathy: The patient takes eliquis.  Reverse with PCC at this time for emergent operative intervention. -hypoxia:  The patient is hypoxic and requiring supplemental oxygen at this time.  This is unclear whether this is related to her COVID diagnosis for her severe abdominal distention. -sepsis:  The patient has evidence of sepsis with the source of ischemic colon.  Administer broad-spectrum antibiotics at this time.  Procedure the operating room for source control.  Continue with hemodynamic support.
Patient awoke this morning and noticed an area (now 4.5 cm) itching and burning. Area is painful to touch, warm, red and raised - localized only.
Nurse reported an unspecified number of unspecified patients received improperly stored PEDVAXHIB, PNEUMOVAX 23 and ROTATEQ.; No additional adverse effects were reported; This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown ages and gender. The patients' pertinent medical histories, concurrent conditions and previous drug reactions/allergies were not reported.  On unspecified dates, the patients were vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) routes of administration, dosage regimens, and anatomical locations were not reported; (lot number R021076 which has been verified to be valid, expiration date reported and validated as 11-JUN-2021), pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) routes of administration, dosage regimens, and anatomical locations were not reported; (lot number S036811 which has been verified to be valid, expiration date reported and validated as 02-AUG-2021) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  administered orally (lot number 1660952 which has been verified to be valid, expiration date reported and validated as 28-MAR-2021). All the vaccines administered as prophylaxis. No additional adverse effects were reported.   The temperatures and time frames reported were: lowest temperature below 36 degrees Fahrenheit (F) (34.2 F) for 34 minutes; lowest temperature below 36 degrees F (34 F) for 37 minutes. Previous temperature excursion were reported: on 05-DEC-2019, lowest temperature below 36 degrees F (32.9 degrees F) for 900 minutes; 07-DEC-2019, lowest temperature below 36 degrees F (34.2 degrees F) for 130 minutes; 10-DEC-2019, lowest temperature below 36 degrees F (33.3 degrees F) for 66 minutes. A data logger was used.  This case has been considered as non-valid due to unspecified number of unspecified patients
sodium level 20; fatty liver; something wrong with kidneys; diarrhea; bone ache; could not walk; fever; confusion; Not feeling good; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever) and CONFUSIONAL STATE (confusion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPONATRAEMIA (sodium level 20) (seriousness criterion hospitalization), HEPATIC STEATOSIS (fatty liver) (seriousness criterion hospitalization), RENAL DISORDER (something wrong with kidneys) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization), BONE PAIN (bone ache) (seriousness criterion hospitalization), GAIT DISTURBANCE (could not walk) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization prolonged), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), MALAISE (Not feeling good) and VOMITING (Throwing up). At the time of the report, HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever), CONFUSIONAL STATE (confusion), MALAISE (Not feeling good) and VOMITING (Throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood sodium: 20 (Inconclusive) 20. In 2021, Body temperature: 104 (High) 104 Fahrenheit. In 2021, SARS-CoV-2 test: negative (Negative) rapid test as well as the PCR were negative.         Patient reported that her liver enzymes were elevated.  Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Chest pain for 4 days which started 5 days after gardasil administration.  Also has injection site pain.
Received Immunization on 8/6/12. Father states some redness noted on right upper am. States by next day, 8/7/12, arm was red, swollen, and looked hot to touch.  Child also c/o itching.   On visit to clinic today 8/9/12, has hot redden area the size of a baseball on the upper right arm. States child was taken to the ER 8/8/12 and was given a "steroid shot" and was to take Benadryl every eight hours.
Right upper arm, redness, itching, hot to touch induration 10-12 cm - cellulitis vs local reaction tx - ice 15 - 20 mins TID, BENADRYL Q 6-8 hr, KEFLEX 500 mg PO BID x 10 day.
acute macular neuroretinopathy I woke up on the morning of 2/11/21 with a very small blind spot in my right eye. I went to the eye doctor and received a diagnosis of AMN with an unknown cause. Fluorescein angiography was performed and they could not discern a cause. In my retina, there was a very small portion of the layer of the photoreceptor cells that was simply missing with no cause able to be seen. The blind spot itself has been stable, and maybe a little better as I write this today. Retinal imaging as of today shows stability/slight improvement in the affected area of the retina.
5.5 cm x 4.5 cm induration rash on stomach, back and chest not itchy. Started this am.