chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe itching all over my body; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (severe itching all over my body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (severe itching all over my body). At the time of the report, PRURITUS (severe itching all over my body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
My child has been screaming nonstop since 5 hours after the shots. It's been 32 hours and if she isn't eating or sleeping, she is screaming. Generally I can put her down in a bouncer or a play mat but she will not have any of that today. She is screaming even when held, walked around, bounced etc. No fever but TYLENOL does. I thing.
there was a nodule in his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NODULE (non-serious), outcome "unknown", described as "there was a nodule in his neck".  Additional information: Reporter was called on behalf her husband who received the Pfizer biotech covid-19 vaccine and after that they realized that there was a nodule in his neck and it was not there before the vaccination and wants to know if this side effect has been reported before. Reaction / Event as Reported  was Nodule in neck, Caller just wanted to see if that's an event and then how to get it resolved because it doesn't seem to be dissipating. Clarifies patient is a Psychologist.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a secretary concerning a female who was vaccinated with her 3rd dose of Gardasil.  Subsequently the patient experienced severe body aches, rash on face and arms, and numbness.  Unspecified medical attention was sought.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a secretary and a physician concerning a 17 year old female who was vaccinated with third dose of GARDASIL. Two days after the vaccination, the patient experienced severe body aches, rash on face and arms, numbness, low grade fever, general malaise and abdominal pain. Unspecified medical attention was sought. She denied any headaches, burning with urination, no nausea, vomiting nor diarrhea. Vital signs were stable. The patient was non toxic and in no acute distress. Ear, nose, and throat were unremarkable. Abdomen is soft and depressible. Active bowel sounds. There was slight epigastric tenderness. No mass, no guarding, nor rebounding. A urinalysis test reported 5 - 10 white blood count with a few bacteria. The physician explained to the patient and her father that this may be related to something other than GARDASIL. The patient was given PREVACID 30 mg capsule once a day as needed for the epigastric pain. BACTRIM DS twice a day for 3 days and to drink fluids. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
No adverse Event; patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD).    No relevant concomitant medications were reported.  No treatment information was provided.
generalized malaise; had an inflamed lymph node on the same side where the vaccine was received for 5 days; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 4), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "generalized malaise"; LYMPHADENITIS (non-serious), outcome "recovered", described as "had an inflamed lymph node on the same side where the vaccine was received for 5 days". It was unknown if therapeutic measures were taken as a result of malaise, lymphadenitis. Additional information: patient took 1000mg of TYLENOL after receiving the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cholecystitis. Awoke 4 days after vaccination with severe upper abdominal pain, vomiting. Seen in ER. Ultrasound showed gallstones. Treated with fluids, pain medications. Will probably require cholecystectomy in the future. Currently pain free.
Arm swelling (site of innoculation), arthralgias in knees and ankles bilaterally 2/9/09-records received for DOS 1/14/09-presented with C/O reaction to immunization received yesterday. Right arm sore with pain going up into shoulders and down left arm as well as into back. Progressed to legs and ankles and feet. Felt tired and weak. Fell and passed out. Prior to passing out felt tired and had blurred vision. Now C/O pain in knees and ankles bilaterally, feels tense in right arm and right hand. Pain is intermittent and stabbing.Assessnent likely to have serum sickness-like reaction to immunization. Joint arthralgia. Swelling at immunization site.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 02-JUL-2018, the patient was vaccinated with a improperly stored dose of ROTATEQ orally, lot # N030175, expiration date 16-JUN-2019 (strength and vaccination site were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at of above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 84 hours. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010994: US-009507513-1807USA010995: US-009507513-1807USA010304.
The patient presented to the ED with COVID 19 and hypoxia, and was found to have an acute T12 compression fracture. At the time of admission to general medicine, she was found to have worsening hypoxia and hypercarbia and increased work of breathing with bronchospastic pathophysiology. She was treated with dexamethasone, remdesivir, bronchodilators, azithromycin for COPDe. She was placed on BiPAP which she tolerated. She was transferred to the ICU for further care. Family was updated and at bedside.
Pain and redness around injection site (2 inch diameter red circle).  Sore throat, nasal congestion, sinus pain, headache, inner ear pain, body aches, fever, coughing, sneezing.  I am still experiencing all of these symptoms (except for the problems around the site injection) 4 days later.  I also developed discharge and redness in my left eye.
I woke up with a sore tailbone even though I hadn?t done anything to it. The next day I looked in a mirror to see if there was an actual bruise and while looking I saw I also had tiny broken blood vessels in the sit bone flesh or the underneath of my buttocks. I hadn?t fallen or been sitting in anything rough and it wasn?t a rash, almost from within. I have never had this before.
made me really sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: This case reported by consumer via interactive digital media. The patient self-reported this case. The patient received vaccine and it made her or him really sick. Follow-up would not be possible as no contact details available.
The second vaccine was given 10 days early because her first dose was administered on 3/25/2021.
Patient reports developing diffuse muscle tenderness throughout body after receiving vaccine that has not yet improved. No fevers, joint swelling/stiffness/redness. Good strength, no changes in sensation. Has not tried any treatment as yet. Was evaluated in 12/2021 by another doctor and diagnosed with fibromyalgia. Patient not accepting this diagnosis, evaluated by me 6/22/2022. I agree with diagnosis of fibromyalgia, patient worried it was triggered by the vaccine and requested that form is submitted
Onset of redness left arm, itching none. PO/BENADRYL cream last NOC 4/19/11 area. 4 x 5 cm of erythema; central 2 x 1/2 cm with induration.
Suffering more intently with some of these; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Suffering more intently with some of these) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Suffering more intently with some of these). At the time of the report, VACCINATION COMPLICATION (Suffering more intently with some of these) had not resolved.            No concomitant medications were mentioned. No treatment details were reported. Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable
Wheezing. Eyes red and swollen with yellow pus. Achy. Unable to lift. Joints sore.
3/6 - slight palpitations 3/7-3/18 - worsening palpitations; had EKG that revealed bigeminal PVCs; on 3/11, had a cardiac workup (ECHO, stress ECHO) - all normal; elevated ALT to 80 but other labs normal; 3/14 - palpitations resolved 4/18 repeated labs - ALT now elevated to 139 & AST elevated to 56; u/s of liver & gallbladder normal
Moderna COVID-19 Vaccine EUA  Woke up the following with a sore throat, cough and runny nose Runny nose lasted only 2-3 hours.  Cough just about dissappeared, but throat still feels a little funny.     I have appt to get tested for COVID at  Urgent care later this morning.
vertigo; vomiting; arm sore; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo. Concomitant products included methylprednisolone.   On 25th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a month after receiving Shingrix, the patient experienced pain in arm. On 26th April 2019, the patient experienced vertigo and vomiting. On an unknown date, the outcome of the vertigo, vomiting and pain in arm were unknown.   It was unknown if the reporter considered the vertigo, vomiting and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had a history of vertigo that was managed by her prescriber. The patient received a dose of Shingrix and the following morning experienced episode of vertigo and vomiting.  She reported that she also experienced a sore arm. The patient gave consent to contact the physician and provided contact details for the same.
26 yo Male developed a laboratory confirmed myocarditis  on/about 7 February 2021 after receiving the 2nd dose of Moderna COVID19 Vaccine on 3 Feb 2021. His HS-Tropin peaked at 2179. He was admitted to the ICU for care. Discharged at 72 hour admission. Seen today (16 Feb 2021) for follow-up. Reports no sequela other than the development of dry skin that is pruritic. Multiple pending  lab studies ordered/collected to identify other etiologies (Lyme, RPR, Coxsackie, parvo ...).  Denies any vaping products.
By the time at hospital severe sx over. Rash with red bumps at injection site, hard lumps x 1 wk a few red bumps on chest - burning on both sites. Clear except for hypopigmentation in center/dker on outer.
Fever (101 degrees): onset 12:30am (14 hours after administration of 2nd dose, lasted 4 hours Tenderness at injection site: onset 6 hours after administration of 2nd dose, lasted >48 hours Light headedness (mild): onset 30 min after administration of second dose, lasted 30 min Malaise: onset 4 hours after administration of 2nd dose, lasted 48 hours Headache: onset 11 hours after administration of 2nd dose, lasted  6 hours Body aches: onset 10 hours after administration of 2nd dose, lasted 36 hours Chills: onset 11 hours after administration of 2nd dose, lasted 6 hours Chills:
Patient was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.  She denied any history of previous adverse reactions to vaccines. She does report a history of similar reaction that occurs fairly regularly after drinking beverages containing alcohol.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience flushed, warm face and ears.  She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, lip swelling and tongue swelling.   This APP was notified of patient reaction and she was then assessed in the emergency bay area.   Vitals Vitals:   12/17/20 1450 12/17/20 1500 12/17/20 1515 BP: (!) 153/73 120/60 138/70 BP Location: Right arm Right arm Right arm Patient Position: Sitting Semi-fowlers Sitting Pulse: 84 79 78 Resp: 14 14 14 SpO2: 100% 98% 98%   Physical Exam  Constitutional: She is oriented to person, place, and time. She appears well-developed and well-nourished. No distress.  HENT:  Nose: Nose normal.  Mouth/Throat: Oropharynx is clear and moist.  Neck: No tracheal deviation present.  Cardiovascular: Normal rate, regular rhythm and normal heart sounds.  Pulmonary/Chest: Effort normal and breath sounds normal. No stridor. No respiratory distress. She has no wheezes. She has no rales.  Musculoskeletal:        General: No edema.  Neurological: She is alert and oriented to person, place, and time.  Skin: Skin is warm and dry. No rash noted. She is not diaphoretic. No erythema.  Psychiatric: She has a normal mood and affect. Her behavior is normal. Thought content normal.    Patient was observed x 35 minutes after receiving vaccination. All symptoms resolved within 20 minutes. No treatment was required. She reports some mild history of anxiety and questions if perhaps she was having a panic attack. She has medication to treat this at home if needed. She was observed x 35 minutes and then released.
Local reaction swelling imm given in left deltoid muscle, swelled up tight and warm no evidence of fluxation.
No adverse effect; Inadvertantly administered one dose of PROQUAD and one Dose of VARIVAX; This spontaneous report was received from a health professional refers to a patient of age and gender. The patient's medical history, concomitant and historical drugs were unknown. On 29-MAR-2019, the patient was inadvertently vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX),(strength, frequency, route of administration, lot number, batch number, expiration date was unknown) and one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(strength, frequency, route of administration, lot number, batch number, expiration date was unknown) (inappropriate schedule of product administration). No adverse event was reported.
Covid Pfizer #2 was injected high into my right shoulder (bursa) area instead of the deltoid muscle area.   Unlike shot #1 on 02/16/21, where I could not even feel the needle in my left arm, this injection into my shoulder was immediately painful.  As the day progressed, my upper arm had to be massaged to reduce the pain, my wrist and fingers tingled, and I could not use my right arm for normal activities.  Overnight, I had difficulty finding a comfortable position for sleeping.  I fear a bursitis condition will develop requiring further treatment.
ER visit @ local Healthcare clinic the next day due to chest pain and other symptoms similar to myocarditis, checklists that I'd seen online. EKG came back normal at that point. Was also experiencing pain under arms, body aches, muscular pain, and feeling feverish. Followed up with personal doctor. Nodes in left armpit got huge within 24 hours, felt like I could feel small grapes or at least raisins in there and the entire area was swollen. Was told to watch things in case following up with a Holter monitor became necessary. Chest pain and tightness persisted at least every other day. Started progressing to get a bit worse a couple of weeks back. Went to the walk-in Clinic when dealing with yet another respiratory infection. Mentioned the pains/tightness and some elevated heart rate episodes I'd had during cardio a few times. Got a Holter monitor for 48 hours. Couple of skipped beats detected but nothing serious. It's progressed to the point where I don't try to do cardio now. Got a 14 day Holter monitor on now. Out of my last 5 runs, I had to abort 4 of them. My heart rate is elevated from the very start, and under what is very minimal exertion for me it hits about 140, then jumps to 170+ and will not come back down until I reduce the load.  This from a minute increase in pace. Yesterday, for the first time, it happened when I was on a slow walk. It didn't increase to the same rate, but I should've been below 85 at that pace and I went up over 130 at points. That's crazy for me; I ran my first half marathon this summer and monitor my cardio very closely.
She got her vaccine, had no reaction other than a little fatigue.  She went to her PCP for routine yearly exam, he did blood work and called yesterday stating that he found out that she had positive ANA markers for autoimmune disease were 160.  She had a negative lab work 12 years ago.  Other lab work is all normal other than this.  She now has an appointment to see a Rheumatologist to see what type of autoimmune disease she has.     She did have her flu vaccine on 9/28/21.
30 minutes later had cold chills.went to bedand slept for 3 hour. Ate something went back to bed and woke up with severe head ache on top of my head. Two days later went to Dr. tested positive with both test. Got infusion 4 days laster. Never left my house for 31 days. Wasn't able to do do anything for another 2 weeks. Lost 12 lbs. Never been this sick in my life
Pt reports "deltoid full of fever"; reported to nurse swelling with home health nurse palpating 5 cm lump with pt reporting continuing to swell "size of silver dollar", arm painful to touch and raise for range of motion.  Pt reports "lump is red, my clavical lymph nodes are swollen and the muscles going up into my neck hurt." Pt advised to continue Tylenol as directed, alternate ice and heat and call back with fever, increase in swellling, pain or redness, body aches and/or chills.
took 2 shots / so bad then shingles 4 years ago; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles 4 years ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not  reported. This case was reported by patient herself. The patient took the shot and would not wish them on his or her worse friend, they were terrible and did leave scars just like chicken pox do. This case was considered as suspected vaccination failure as details regarding  time to onset for target disease (shingles) and laboratory confirmation were unknown at the time of reporting. The reporter stated that 2 of his or her sister's did not take them but 1 and he or she, did an slept in the same bed till mamma had to make him or her a bed in a chair away from the other kids. The patient had them so bad than the shingles 4 years ago. The patient received the 2 doses of shingrix and experienced shingles and suspected vaccination failure. This case was likned with case US2021AMR077290 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077290:same reporter US-GLAXOSMITHKLINE-US2021AMR077311:same patient
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (route, dose#, site of administration and lot# not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested.
Pain in right arm began about 7 hours after injection.  I slept on my left side all night because right arm hurt.  It especially hurts when I lift my arm.  It also aches and tingles up and down entire arm and up through my neck, around to back shoulder blade and up through cheek.  My ear is "congested" and hearing is impaired and my ear tingles also.  I slept the entire night on my left side so it wouldn't be that fluid settled there over night.