chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive for COVID-19 after completing the full Moderna vaccine series, 50 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 2/11/21. Tested positive on 4/2/21. NOT hospitalized. "Symptoms: cough, loss of taste, loss of smell;  Symptom onset date: 4/1/2021"
Extreme fatigue and joint pain starting April/May; elevated AST/ALT levels in June; confirmed diagnosis of Autoimmune Hepatitis in July; confirmed diagnosis of Sjogrens in September.
p/vax pt c/o h/a, upset stomach & weakness;no rash seen by ER given med;
Hot hive-looking red spot at injection spot,  severe body aches,  severe chills, severe headache, fatigue, dizziness, skin pain,  back  and neck pain, stiff neck, severe pain on entire left arm
5/10/07 0830 in ER with swollen, hot hard rt deltoid with c/o excessive pain and unwillingness to use arm. Pain rated 8 on 1-10. Blood drawn. no infection noted. Warm packs and NSAID. 5/1107 0900 back in ER. "Twice as big" "hard", "head hurts", "stomach hurts", per mother. Augmentin and Hydrazine given. Approx 12" x 8" per mom. 5/14/07 called mom. Went to another ER, was prescribed steroids per mom, all better. Will follow up 5/18
CHILLS; This spontaneous report received from a patient 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
6cm x 5cm bruise 7 inches below injection site x 2 days post inject.
pt presented to ED after recent hospitalization for AHRF due to COVID; received Decadron, Eliquis, and Remdesivir during hospitalization; was dc'd to home on 2L O2; while @ home O2 sats were worsening while pt was @ rest (88-90% on 5L O2); pt was seen by NP, who suggested chest xray and lab work; pt decided to come to ED for eval; presents with mild, productive cough; COVID pneumonia; given antibiotics; persistent hypoxia even on 15L O2: transferred to ICU; placed on BiPAP; later required intubation; pt's condition worsened and family opted for comfort measures; pt was extubated and died in the hosp
(2pm) A few minutes after injection, patient complained of feeling dizzy & hot. She was helped to a chair, drank some Coke-cola, still felt dizzy & helped to lie down. She then felt better, drank more cola. After eating soup & juice she felt better. (240PM) BP at 2 PM 64/50; pulse - weak BP at 240PM 115/68 pulse 80.
new lot / was administered / asking to know if they could continue using that lot of vaccines; 3 out of 18 patients fainted; This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. In August 2021, less than a week after receiving Menveo, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fainting and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the fainting to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called to report, a new lot of Menveo was administered to 18 patients since 2nd August 2021. The patient fainted after receiving the Menveo vaccine.  The health care professional called on behalf of a nurse manager who was asking to know if they could continue using that lot of vaccines.  The health care professional who made the call did not have any patient's demographics information nor vaccine information. Follow-up was not asked because the health care professional who reported the event did not have any information. On 5th August 2021, call back to nurse manager, but she was not available.  As per the judgment there has to be a Regulatory Authority associated, for that the health care professional was transferred, but not sure if they collected it, because the agent said it was not, and afterwards she took the call. The data in health care professional detail was from the nurse manager who has all the information on the event. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR167723:Same reporter US-GLAXOSMITHKLINE-US2021167017:Same reporter
Injection site, sore, red and developed a pustule, Patient had no strength, fell, lasted 2-3 days.
My arm was initially sore after receiving shot on 8/8/13 but a month later pain increase into top shoulder. It's hard to sleep.
pt recvd vax; pt exp severe pain-excruciating of Lt entire extremity-has now affected Rt arm also-as if someone is chewing on shoulder bones & hip bones; temporary paresthesia/paralysis dec extremities-reflex sympathetic dystrophy Lt arm;
TRIAGE CALLED due to syncopal episode 1:31pm pt got administered 1st Moderna covid vaccine and immediately passed out. RN called triage immediately after at 1:31pm and Dr arrived at seen 1:32 pm. 1:33 pm EKG done NSR, BP 110/90 HR 78 (lowest was 37), temp 98.3, O2 97%, Blood sugar 104.  1:38 pm 911 called Time of EMS arrival and transport pt is awake, alert, oriented  MD notes: I arrived beside to patient after she lost consciousness in her chair. She had just received her COVID19 Moderna vaccine. Her arms were shaking and she was not rousable. She then regained consciousness and appeared confused, asked how long she was out for, and said she knew she was going to pass out. Then as she was speaking her eyes sort of rolled to the side and she lost consciousness again. Her right arm became stiff. She regained consciousness and said she felt very hot. She was diaphoretic and had a very slow pulse. Pulse ox recorded saturation 97% and heart rate as low as 37. She lost and regained consciousness one more time. EKG done which showed normal sinus rhythm, no concerning ST changes on initial glance. POCT glucose 104. EMS arrived to take patient to ED.
Pt given injection 02/13/2009 @ 4:00pm 36 later Pt states fever of 100, chills body ache L arm, headache.
Two days after vaccine booster developed unexplained paroxysmal surge in hypertension accompanied by new onset atrial fibrillation with rapid ventricular response that lasted 10 hours and self-terminated.  Accompanied by chronic fatigue syndrome, which has persisted.
The night I got my first Covid vaccine, the left side of my face started to tingle and my jaw began to hurt. I took Tylenol and Ibuprofen, but the pain didn't subside. I made a doctor's appointment  on 2/25/21, which is when I was diagnosed with Bells Palsy.
Patient started to develop itching and a little pain to right arm at area of vaccine site 1 week after vaccine. At that point, had 3 small red dots. Progressed over the last several days to a red, warm area c/w cellulitis. To be treated today with Keflex.
Patient hospitalized within 6 weeks of receiving COVID vaccination. Admission was 3/18/21 for abnormal stress test. Length of stay was 7 hours. He was admitted on 4/14/21 with multiple vessel coronary artery disease. Length of stay was 6 days.
On 06/19/2021  was noted to have decreased energy and temp was ~100, tylenol given. A few hours later after completing his morning therapies he showered and went to take a nap. At this time he was febrile to 103.6.  At 1600 he had seizure-like activity with trunk and upper extremity shaking as well as eyes rolling back and drooling.  Parents put him in car and transported him to an outside hospital. He did stop seizing prior to getting to that hospital.  Parents reported seizure lasted approximately 15 minutes with no loss of bowel or bladder control.  By time he arrived at local emergency room he was back at his neurological baseline. At the outside hospital our PICU was consulted and he was given ceftriaxone and vancomycin in meningitic dosing.
shingles on the right eye; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 10-MAY-2018, the pt was inoculated with zoster vaccine live(ZOSTAVAX), as prescribed and/or administered by a healthcare provider at a physicians office for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a physician for shingles on the right eye. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   Upon internal review, shingles on the right eye was determined to be medically significant.
Fever,Joint Pain, Weakness, Gastric Pain starting aprox 7:00pm 6-15-18 and continuing through 6-22-18.
felt no energy; wasn't feeling that great; felt so tired; soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in left arm), ASTHENIA (felt no energy), FEELING ABNORMAL (wasn't feeling that great) and FATIGUE (felt so tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, METOPROLOL and METFORMIN for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm). On 05-Apr-2021, the patient experienced ASTHENIA (felt no energy), FEELING ABNORMAL (wasn't feeling that great) and FATIGUE (felt so tired). At the time of the report, PAIN IN EXTREMITY (soreness in left arm), ASTHENIA (felt no energy), FEELING ABNORMAL (wasn't feeling that great) and FATIGUE (felt so tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
pt recvd vax; that eve had fever of 105;next day in ofc t was 104 but then sz (felt to be febrile);was somewhat dusky,adm to hosp; did fine & was discharged; OK on f/u visit
Two weeks after second shot, large bruise appeared.  Pain increased in muscle upon movement or pressure.  Began to recede slowly after five (5) months, still some pain at six (6) months.
24 hours later, febrile seizure occurred. Patient has never seized, nor had any reaction with Covid-19 vaccines #1 or #2.
Collapsed in waiting, exp seizure like activity. Waiting room occupants heard hit floor solidly. Vital signs stable. RN didn't observe seizure activity.  911 called and transported to ER.
light-headed, dizzy, nausea, rest, fluids, good recovery;total time 45min;
Information has been received from a physician concerning a 5 year old white male who on 07/18/00 was vaccinated with the 2nd dose of MMRII, in the right thigh. Two to three weeks, post vax, the pt was seen in a physician's office, after having developed a disseminated measles-type rash. It was noted that the pt had a fine rash over both arms. The reporter also noted that the pt develo9ped an increased temperature of 101.6F, bilateral leg pain and an ulcer on the tip and left side of the tongue. The pt received treatment with fluids, acetaminophen (Tylenol) and ibuprofen (Motrin). On an unspecified date, the pt recovered. No further information is expected.
chills; This is a spontaneous report from a contactable healthcare professional, the patient. A 21-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL0142, intramuscularly in the left deltoid on 06Jan2021 at 08:00 (at the age of 21-years-old) at 0.3 "mg" as a single dose for COVID-19 immunization. Medical history included birth control use and obesity. Concomitant medications included ongoing ethinylestradiol/norgestimate (SPRINTEC) tablet for birth control. The patient did not receive any vaccinations within 4 weeks prior to the vaccination. The patient previously took methylphenidate hydrochloride (CONCERTA) 27 mg and experienced lack of appetite and was still having sleepiness (insomnia she guessed) and therefore was dropped to 18 mg and still had side effects; as well as guanfacine. On 07Jan2021 at 21:00, the patient experienced chills. She thought it was just her mom's house being cold, but she had a little bit of a chill all day today (08Jan2021). She didn't have a fever. The last time she took her temperature it was 98.5 degrees Fahrenheit, which was normal for her. The caller stated she did have a slower metabolism when it came to medication. She didn't know 100% if she hadn't been exposed to COVID, as she worked in healthcare and worked last on Monday. The event, chills, did not prompt an emergency room or physician office visit. The caller was worried if this was a normal side effect of the vaccine or if she was getting sick with COVID. She would go through with the COVID test she had scheduled for "tomorrow morning" as she was still experiencing side effects. The chills stayed the same or were a little worse. The clinical outcome of chills was not resolved.
None (Patient was 16 years of age, scheduled for the Pfizer vaccine and received Moderna)
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 2:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's age was 35.64 years.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pain growing and becoming severe and acute. Dizziness and head ache. Two tabs of Tylenol had no effect on pain. On scale of one to ten it was an eight by late that night and all the next day. The next day my arm from my shoulder to my elbow turned red with some pouching below the elbow of some drainage. By the third day the pain began to back away and only had to take one day off from work.
Kidney infection; very anxious and started to feel panic; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZLA or L:039AZlA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety. Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant) and ANTICIPATORY ANXIETY (very anxious and started to feel panic). The patient was treated with ALPRAZOLAM for Anxiety, at an unspecified dose and frequency. At the time of the report, KIDNEY INFECTION (Kidney infection) had resolved and ANTICIPATORY ANXIETY (very anxious and started to feel panic) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant products also included Supplements for an unknown indication. Treatment information included unspecified Antibiotics for kidney infection for 14 days.  Patient stated that she was not sure of what happened or if her defenses went down.  Company Comment: Very limited information regarding the event Kidney Infection has been provided at this time.  Further information has been requested. There is at least a timely relationship between the event and the vaccination date. The event Anticipatory Anxiety is rather related to the patient´s medical history of anxiety.; Sender's Comments: Very limited information regarding the event Kidney Infection has been provided at this time.  Further information has been requested. There is at least a timely relationship between the event and the vaccination date. The event Anticipatory Anxiety is rather related to the patient´s medical history of anxiety.
Patient states he got the covid vaccine in the morning on 4/30/2021 and by afternoon he was having difficulty walking - states he was having trouble picking his feet up. Patient states he was feeling weak and the next day had to start using a cane (walked without assistance prior to vaccination). Patient states he started losing feeling/strength/movement in feet and legs 4/30/2021, with the weakness/paralysis moving up the legs over the course of a month. Patient states he went to primary doctor approximately 3 weeks after his vaccination and reported his symptoms but his doctor "wasn't concerned". On arrival to the ER 5/31/2021 patient was totally unable to sit up unassisted and stated his decreased sensation and loss of movement had risen to bilateral hips. Patient had to be lifted to the stretcher by four staff as he was unable to help at all, with legs dangling/flaccid paralysis obvious. Patient also reports loss of bowel/bladder control since vaccination - states started losing that control as decreased sensation/movement ascended to hips/pelvic region.
Woke up on the 11th with a horrendous headache.  Lasted about 3 hrs.  Woke up on the 12th with a bad headache and dizziness.  Headache went away after 2-3 hrs, but dizziness lasted until the afternoon of Dec. 14th
patient was seen on 10/28/20  with c/o pain over the left arm , shoulder and back. dx as possible shoulder tendinitis and referred to PT. PT expressed concern of Parsonage Turner syndrome, and this was discussed with patient, we started patient on antiinflamatory and prednisone taper and  referred to neurology  for confirmation. Patient did not follow up with neuro due to cost of evaluation involved and follow up with us today, 02/12/21. per patient pain has improved a little,~10%, but still has discomfort when he lays on his back on left shoulder with pain that is burning in nature. also has associated mild weakness in the left arm. patient was explained the d/d and treatment options. we started him on gabapentin 300mg QHS to help with the neuropathic pain. also advised patient to continue with PT exercises as recommended by the therapist.
I had severe arm burning while shot going in.  It never went away and was noticeable when laying on the arm.  I?ve started working out and the pain has intensified to the point that it is radiating to my neck and back and I cannot sleep on that side.  It sometimes is a deep throbbing pain and other times feels like sand paper.  Last week I noticed a small scab right where the shot was.  I picked it off and it bled a lot.  Since then the pain is almost constant and limiting my daily abilities.  Red dot remains where the shot was administered.  Sometimes feels warm to the touch. This is staring to cause me distress and  worry.  I had two boys that just got first vaccine but I don?t think I will be getting them the second.    I work in health care and I?m finding it difficult to do my job at times.
Information has been received from a health professional concerning a 12 month old white female birth twin with no other medical history who on 23Sep04 (previously reported as 24Sep04) at 3:30PM was vaccinated SC in her left arm with a first dose of varicella virus vaccine live (lot 646674/0709N).There was no illness at the time of vaccination. On 26Sep04 (previously reported as 27Sep04) at 6:00PM, the pt reported to the office with mild varicella all over her body (face, torso, legs). The pt was being treated with hydroxyzine hydrochloride (Atarax) and oatmeal baths. The outcome was reported as not recovered. Unspecified medical attention was sought.  There was no product quality complaint involved. Follow up information form the health professional indicated that the pt's lesions lasted 4-5 days and the pt was now recovered. No further information is available. The reporter also indicated that the pt's twin brother developed mild varicella after vaccination (WAES0409USA02259).
complaints of increased cough and shortness of breath starting  12/21, placed on 2L O2 started on dexamethasone 6mg daily and remdesivir
Macular rash noted 20-24 hours after receiving MMR, Varicella.  Rash generalized.  No temperature or other symptomatic symptoms.