chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm got stiff; It itches; rash all over her body/it started spreading all over her body/red spots all over her body; rash on her right arm where she received the vaccine; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm got stiff), PRURITUS (It itches), RASH (rash all over her body/it started spreading all over her body/red spots all over her body), VACCINATION SITE RASH (rash on her right arm where she received the vaccine) and VACCINATION SITE ERYTHEMA (red at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus since an unknown date. Concomitant products included HYDROXYCHLOROQUINE for Lupus erythematosus, LEVOTHYROXINE for Lupus syndrome.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm got stiff), PRURITUS (It itches), RASH (rash all over her body/it started spreading all over her body/red spots all over her body), VACCINATION SITE RASH (rash on her right arm where she received the vaccine) and VACCINATION SITE ERYTHEMA (red at the injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm got stiff), PRURITUS (It itches), RASH (rash all over her body/it started spreading all over her body/red spots all over her body), VACCINATION SITE RASH (rash on her right arm where she received the vaccine) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.
HISTORY OF ASTHMA AND UNKNOWN ALLERGIES, 15 MIN AFTER RECEIVING VACCINE COMPLAINED OF DRY THROAT, COLOR PINK, NO HIVES, NO EDEMA, NO SHORTNESS OF BREATH, BO 120/70, P100.  MOTHER NOTIFIED AND REQUESTED BENADRYL.  BENADRYL 12.5MG PO GIVEN AT 11:11AM.  RESTED 15 MINUTES, FELT BETTER AND WENT BACK TO CLASS.
I cut my thumb on a safety razor while removing cap. Since I could not remember my last tetanus booster. I had TD booster to left arm given by co worker RN. On Thursday my arm was swollen, bruised and sore. I took Benadryl and placed ice on my arm. By Sat 9/30/06 my arm was swollen to the size of a soft ball. It was bright red and hot to touch. After receiving ROCEPHEN, SOLU MEDROL and BENADRYL in ER I returned home. Approx 21:30 that night I felt funny and began having difficulty breathing. I returned to ER and was admitted to observation. DX: Cellulitis versus allergic reaction. Chief complaint: left upper arm swelling and redness. Returned later same day with difficulty breathing. Treated with oxygen, 2 grams ROCEPHEN, BENADRYL 50 mg IV and 62.5 mg of SOLU MEDROL.  Allergies to Penicillin, BIAXIN and bee stings. VSA: BP 118/74, temp 99.1. Swollen, indurated and tender left upper arm at the lateral to posterior area. 12x9 cm.
Sxs: Shortness of breath, itching eyes, redness, dysphagia, rash, tachycardia. Tx: Depo-Medrol 80mg IM, 0.2mg Epinephrine IM. Monitored x 1.5 hrs. Sxs resolved.
developed mild to moderate COVID; developed mild to moderate COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 20 year-old patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "developed mild to moderate COVID". The event "developed mild to moderate covid" and "developed mild to moderate covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right thigh had DTaP #5 in that thigh got a reaction site got red and swollen.
1cm local reaction on R thigh 2 days after shot, " lost control of head and became like a baby, pale, then vomited" ok since
I'm not 100% sure which manufacturer's flu-vaccine was used. I check the first in the list only because it was an Influenza choice. The malaise and cephalgia in the first 24 hours was expected, but the 10 hours of chills and rigors that came on at 36 hours post vaccination caused me to report. Today is 10/1/18 and I'm just feeling better.
BLOOD PRESSURE ISSUE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On MAR-2021, the subject experienced blood pressure issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure issue was not reported. This report was non-serious.
A serious post-marketed study report of hydronephrosis and ureteritic obstruction has been received from a study investigator concerning a four-year old male subject, patient ID 53390614, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this subject. The subject received FLUMIST on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstruction. The subject's length of hospital stay was two days. The outcome is unknown. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2015, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical group office (by an unspecified health care professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Patient began experiencing itching at the injection site and then all over her body. She started feeling very warm and developing hives. She was given diphenhydramine 25mg by mouth. 911 was called and she was taken to the ER. The ambulance arrived about 5 minutes after 911 was called.
In the same evening of doses 1 and 2 I developed left sided chest pressure and burning that radiated down my left arm. The dose 2 episode additionally radiated into my left neck and jaw. I have had an increase in heart palpitations. I have had a headache since the day after the 2nd dose (August 22 was the day of 2nd dose).   Separately from the above I had metallic taste in my mouth minutes within injection on both doses that lasted until later in the day.
The patient came in for her second dose of Moderna and had concerns because she stated that she developed a nose bleed the day after she received her first dose. She stated that she also passed clots and her nose bled for more than 1 day. She stated that she went to the ER but was only given a nasal spray to use. She denied a history of nosebleeds and does not take blood thinners.
At 1555 participant walked back into Vaccine Site covid monitoring area and c/o SOB & tongue edema; was post 1st Pfizer Covid vaccine at about 1525. At time participant escorted to monitoring cot and laid down. She explained experiencing chest tightness and feeling of tongue swelling upon exiting building post vaccine; she attempted to sit in car until s/s ended but no improvement. 1555 B/P 151/ 85, P 79, O2 Sat 99% with noted tongue edema / SOB. 1558 Called 911 and on site clinical assist alerted. 1559 Benadryl 50 mg IV given via left deltoid by RN. 1600 BP 140/82, P 71, R 18, O2 sat 99%. Noted allergy hx; yeast, mold, grape seed oil. 1603 Participant voiced feels decrease in tongue swelling and more relaxed feeling; no noted skin redness - BP 122/89, P 70, O2 sat 99%. At time EMS arrived on scene and began assessment. 1610 EMS assessment completed and participant declines transport to hospital; voiced will monitor self at home & call 911 if s/s return. 1614 BP 140/83, P 73, R 18, O2 sat 99% with visible noted decrease in tongue edema. 1615 Participant remains semi reclined on cot and making attempt to contact husband for transport home. 1619 took few sips of H2O with no difficulty swallowing. 1626 BP 115/91, P 62, O2 sat 99%. 1629 Attempted to stand participant and noted c/o dizziness, HA and feeling that tongue edema was returning; returned to cot in lying position. Assessed; clear lungs, noted increase in edema, no SOB - O2 sat 99%. 1630 EMS called to site; BP 148/96, P 62, O2 sat 99%. 1637 EMS arrived on scene and resumed care. 1641 Participant leaves site via stretcher with EMS for transport to hospital. Participant's husband arrived on scene and given participant's purse and car keys per her approval.
Mild fever 37.5-37.6 C accompanied by mild headache and moderate to severe pain in joints and body much like arthritis and flu-like pain in joints.  Pain mostly resolved after 48 hours.
Patient's vaccine site remains tender to the touch,  one month after date of vaccination. Patient gets intermittent pain down the arm of the vaccination site. The injection site was approximately 9cm below the acromion process.
Breakthrough COVID illness; Breakthrough COVID illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) , single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough COVID illness". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Unknown result. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201064256 Same patient and product, different dose and event;
FEELING HORRIBLE; LOSS OF APPETITE; SWEATING; ACHY; CHILLS; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-MAR-2021, the subject experienced tired. On 03-APR-2021, the subject experienced feeling horrible. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced achy. On 03-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, and had not recovered from chills, sweating, achy, loss of appetite, and feeling horrible. This report was non-serious.
I felt numbness/tingling in right hand and right foot upon wakening (5:00 AM) on 4/19/2021.  I further developed numbness on right side of face around 8:00 AM on 4/20/2021.  I went to ER and was admitted to hospital on 4/20/2021.  Tests confirmed TIA.  Discharged from hospital on 4/21/2021.  Numbness persists.  Prescribed aspirin, Plavix, and Lipitor while in hospital and upon discharge.   Will follow up with family doctor and neurology in next few weeks.      Item #21 won't allow me to enter the number of days hospitalized or the hospital name so I will enter it here:  I was hospitalized from 4/20/2021 - 4/21/2021 (two days) at Hospital.
Narrative: The patient indicated he developed a rash one week after the first dose administration on 1/15/2021.
shingles on breast, neck, back, hairline; miserable; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's son got shingles but he was not vaccinated against shingles).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles and feeling miserable. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the feeling miserable was unknown.   It was unknown if the reporter considered the shingles and feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that, she got a shingles shot about a year ago from the date of reporting. She had 1 shot (not 2) and also did not know the name of the product (if it was Shingrix or Zostavax). The patient reported a couple days after getting the shot had got a shingles outbreak on her breast and back and up around her neck and hairline which made her miserable. Because she did not know which shingles immunization she received, she provided the phone number to the pharmacy where she got the shot.
Hemorrhagic stroke. Hospitalized, ventilator. 11/10/09 Medical records received for DOS approximately 10/24/09-11/2/09. Final DX: Intracranial hemorrhage Found unresponsive, severe HA, nausea, vomiting, intracranial hemorrhage. Intubation. Pleural effusion, Dysphagia. Feeding tube. WBC increased.   12/10/09 DC summary and hospital records received for dates 10/24/09. DX: rt basal ganglia hemorrhage w/ assoc intraventricular hemorrhage, left frontal hemorrhage, resp. Failure, UTI. Pt family state found pt. down. Assessment: Glasgow coma scale 61. Pt admitted IVC placed, pt intubated. PEG tube placed after failed swallowing test. PICC line placed. At time of dc pt stable.
Moderna vaccine was given as 2nd dose when 1st dose had been Pfizer.
almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot number was not reported) (age at vaccination: 43-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, and allergies: Penicillin. Concomitant medication included levothyroxine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient was not pregnant. The patient experienced racing heart, tingling hands, almost passing out, dizziness. She was driving so she pulled over and called(#). Symptoms improved enough so that she did not request an ambulance. 10 minutes later she was home and became lightheaded again which has not resolved. It has been 1.5 hours since her dose. Adverse events started on 15Apr2021. No treatment received for the events. The outcome of events was recovering. Information on the lot/batch number has been requested.
Pt started complaining of right thigh pain, mother noticed some limping, and swelling. Mother applied ice to effected area, pt slept. Did not have any issues over night, this morning patient continued to limp, and thigh got more swollen extending towards knee.
Day after shot, began having very mild spotting every day. Then, 13 days after shot, got a period (had just finished a period 2 weeks before).
Got shot at 11:15, went out to lunch and for a haircut, about 2:00 pm c/o extreme itching on upper thighs and Mom discovered an angry bright red raised rash that mottled and began all joining together into one large solid welt covering the thighs bilaterally from hip to knee. Took him to the pediatrician immediately and by then the rash existed on both forearms and the forehead in addition to the thighs. Given 4 fast melt tablets of Benadryl (adult dose since weight 110 lbs) and observed for 45 minutes in doctor's office. Temp was 100 degrees. Examined by Drs and allowed to go home after rash subsided. Parents instructed to give Benadryl q 4-6 hours for the next four days. Mother reports on 6/6/07 that some redness was starting again last night but went away after Benadryl was administered. Patient is sleepy from the Benadryl but is doing well.
No injection site trauma. No different than annual flu vaccine.   Onset of symptoms noticed next morning.  Barely able to get out of bed, extreme exhaustion and apparent loss of brain function. Dazed.  These continued over the next few weeks, lessening over time.  What occurred during that time were aches in different joints.Knees, elbow, shoulder etc.  Extremely old injuries were brought back.  3rd week most of muscle and joints aches subsided.   To this day there are sudden bouts of lethargy and exhaustion.  occasional joint aches but how much of that could be related to old bones. The brain confusion continues. No seeming trigger to bouts.
Vaccine administered 2 days after "used by date of 7/28/21".  This is the Last date of  use after being in the refrigerator with temp.  of 4.7C
1/16/2021. Large swollen lymph nodes under high jaw and down front of neck.  Very tender to touch and painful to swallow and move neck.  1/17/2021: woke up with worse neck pain and palpable lymph nodes in neck.  Headache. 1/18/2021: woke up at 3AM with weakness on left arm and left leg.  Continued pain in neck.  Tingling on lips.  Intermittent tingling and warmth on face.  Went to Urgent Care.  Released after EKG and stroke discussion with assurance I would go to ER with any changes.  1/19/2021: woke at 3:30AM with facial tingling/numbness and worsening left side weakness and tingling.  Went to ER.  EKG - normal.  Brain MRI for stroke - normal.  Blood work - normal.  Released with assumption of vaccine reaction.  Referred to neurologist.
S/post injections. Infant exhibited red macular rash on trunk and extremities. Infant was also red from strenuous crying. No hives. No respiratory stress. Treated. Detained for 15-20 minutes, rash resolved. Infant took bottle, burped and was sleeping comfortably when departed.
pneumonia; got both strains of flu; Initial information received on 24-Dec-2022 regarding an unsolicited valid social media serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced pneumonia and got both strains of flu after receiving vaccine influenza vaccine.  The patient's past  medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot, expiry date: not reported) via unknown route at unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date (unknown latency) the patient developed a serious pneumonia and got both strains of flu (influenza) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for both the events.  Seriousness criteria: Medically significant for pneumonia.; Sender's Comments: Sanofi company comment dated 28-Dec-2022: This case involves an unknown age and unknown gender patient who experienced pneumonia after receiving vaccine influenza vaccine. Additional information regarding condition at the time of vaccination, concomitant medication, medical history would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
I woke up on 11/13/2014 and had a sharp pain in my back and my arms started going numb, an ambulance was called and I went to the ER, they sent me home saying I had a pinched nerve.  I came home and throughout the day the numbness continued from my neck down to my toes and I went back to the ER in the evening and by the time I got there I could barely open my hands, had to be fed, could barely walk, was extremely uncomfortable and thought I would be in a wheelchair the rest of my life. I was finally discharged on November 19th after many many tests and diagnosed with ideopathic myelitis as I had swelling in my spinal cord.
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with depression, obesity, hypertension and no known drug allergies who on 23-SEP-2009 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # 662300/0100Y). Concomitant therapy included labetalol HCl. On 12-OCT-2009 the patient had a positive urine pregnancy test. The patient sought medical attention through an office visit. Last menstrual period and gestational age were unknown at the time of the report. Follow up information had been received from a registered nurse and was reported that the patient had a "missed abortion", and a Dilation and evacuation (D & E) on 13-NOV-2009. Upon internal review, the missed abortion was determined to be an other important medical event. Additional information has been requested.
pt recvd vax to lt deltoid area started to be firm & swollen p/24hrs; ROM WNL; warm compresses applied
red & itchy feet & redness between fingers on hands & onto palms started 5 days p/receipt of flu vax;
Patient began to experience new onset syncope upon normal exertion approximately 2 weeks post 2nd dose.  Patient was treated at local ER with no significant findings. Patient died 4 days later.  Patient was treated in ER for new onset of syncope a number of times between vaccine and death 5 months later.
ACUTE RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY