chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started as a severe headache. I had ringing in my ears, nasuea, fatigue, vomitting.
Injection site is swollen, red, and hot to touch.  Pt also c/o chills, stating he "feels like he has the flu".
Several hours after the booster I had a severe headache, sweats, the symptoms disappeared but several days later I had episodes of similar headache pain  with lightheadedness and high blood pressure. Saw cardiologist who did blood work, stress test, evaluation and said everything was normal except for the HBP for which he prescribed a low dose HBP medication. Symptoms did not improve but progressed to pressure in the ears, disequilibrium and migraine-like headache. Had ENT visit and was diagnosed with vestibulopathy.  Symptoms did not change for several months. I then saw a Neuro Otolaryngology at local Eye and Ear. I had an MRI, hearing exam, and vestibular lab exam. Tests were normal. MRI normal.  Blood pressure is still high, vestibular symptoms persist, migraine headaches. I have no history of headaches. No history of high blood pressure
9/25/13 - Flu vaccination at primary care clinic. 9/26/13 - Shingles vaccination at pharmacy. Developed numbness and tingling in feet after immunizations. Time frame uncertain. Symptoms progressed to hands, then lower extremities from feet to knees. Reported to ETC on 10/30/13 when experiencing difficulty ambulating. Dx: Guillain-Barre.
developed shingles after receiving second dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles after receiving second dose of Moderna) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (developed shingles after receiving second dose of Moderna). At the time of the report, HERPES ZOSTER (developed shingles after receiving second dose of Moderna) outcome was unknown. Not Provided          No concomitant medication information was provided. No treatment medication information was provided.
Fatigue, dry cough, and moderate to severe injection site tenderness/soreness at injection site ~5 hours after injection; progressed to chills, body aches, fever, and severe injection site pain (R deltoid) restricting movement and use of limb overnight into morning.
arm is tender, sore, just got worse, on underside of arm; Forearm itches; Injection site is irritated; arm is itching; Injection site is swollen; tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at injection site), TENDERNESS (arm is tender), PAIN IN EXTREMITY (arm is sore), PRURITUS (arm is itching) and PRURITUS (got worse) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (tenderness at injection site). On 27-Jan-2021, the patient experienced TENDERNESS (arm is tender), PAIN IN EXTREMITY (arm is sore), PRURITUS (arm is itching), PRURITUS (got worse), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE DISCOMFORT (Injection site is irritated) and PRURITUS (Forearm itches). On an unknown date, the patient experienced PAIN IN EXTREMITY (was on underside of arm). At the time of the report, VACCINATION SITE PAIN (tenderness at injection site), TENDERNESS (arm is tender), PAIN IN EXTREMITY (arm is sore), PRURITUS (arm is itching), PRURITUS (got worse), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE DISCOMFORT (Injection site is irritated) and PRURITUS (Forearm itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication Treatment for the events, included benadryl
Facility accidentally gave her an expired vaccine  it was out of the fridge for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Facility accidentally gave her an expired vaccine  it was out of the fridge for 12 hours) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Facility accidentally gave her an expired vaccine  it was out of the fridge for 12 hours). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Facility accidentally gave her an expired vaccine  it was out of the fridge for 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  The patient was reported to be a breast-feeding mother of a four-month old.    This case was linked to MOD-2021-252960 (Parent-Child Link).   See case MOD-2021-252960 for details regarding the child case.
Had taken an unrefrigerated dose; Did not experience any adverse effects; Spontaneous report received on 30DEC2019.  A 69-year-old male consumer reported that he "had taken an unrefrigerated dose" (PT: Product storage error) and did not experience any adverse effects (PT: No adverse event) while being on Vivotif (lot number: 3003302; expiry date: Sep 2020) for immunisation. The consumer took one dose unrefrigerated Vivotif (21DEC2019 or 28DEC2019) and did not experienced any adverse effect due to that unrefrigerated dose. He stated that he was not taking any concomitant medications. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took an unrefrigerated dose of Vivotif (incorrect product storage) and did not experience any adverse event (No adverse event). The causality of both the events is assessed as not applicable.; Sender's Comments: A consumer took an unrefrigerated dose of Vivotif (incorrect product storage) and did not experience any adverse event (No adverse event). The causality of both the events is assessed as not applicable.
Reporting approximately 180 instances of monovalent boosters being given in the time frame between the deauthorization by the FDA and the arrival and implementation of the bivalent booster.  A few instances were due to patient request that they had to have another dose before the new boosters were available to be able to travel to another country and other issues. Most instances were staff not getting or under-standing the messaging to stop using the monovalent boosters even though the recommendation was turned off in our electronic health system.
Developed a knot and a rash with fever at injection site of either varicella or Hep A, one week after receiving vaccines. Rash was raised and rough but no vesicles. Suspect its a vigorous response to the vaccine.
On 8/25/93, the infant developed a fever of 104 and viral croup. He was hospitalized. Subsequently, he developed a bleeding rash on his cheeks and was reportedly dx with autism. The mother attributed these events to the vaccines he received since the age of 4 months. She also believes that the preservative thimerosal is related to the development of autism.
On 7/16/23, 5-days after my second dose of Shingrix I experienced an itchy red, slightly raised rash with burning sensations on my right lower back (dermatomal pattern). I went to urgent care on 7/18/23, was diagnosed with shingles, and started on Valtrex. The rash was mild and resolved in about a week.   I had previously experienced shingles in Sept 2022 (right mid-back and abdomen), was also seen at urgent care, and treated with Valtrex. The episode of shingles in Sept was much more severe - quite painful with burning sensations, fatigue, pronounced vesicles, and the rash lasted several weeks.  I received my first dose of Shingrix on 2/7/23 (lot 429MK).
PATIENT REPORTED RASH LIKE REACTION AT INJECTION SITE, ARM 'BURNING' SENSATION, FEVER, HEADACHE AND AN OVERALL "BAD" FEELING.  SHE STATED THAT THE REACTIONS BEGAN THE EVENING OF 8-8-19 AND PERSISTED TO VARYING DEGREES UNTIL AND INCLUDING 8-13-19.  THE RASH SEEMED TO CONTINUE TO GET LARGER (APPROX 5 X 4" ON 8-12-19) AND SHE FELT IT SHOULD BE ASSESSED.   SHE CALLED THE PHARMACY AND SAW HER MD ON 8-12-19 AND WAS PRESCRIBED CEPHALEXIN IN CASE IT WAS PROGRESSING TO CELLULITIS.  AS OF 8-12-19 ALL SYMPTOMS EXCEPT FOR THE RASH HAD RESOLVED PER PATIENT.
Immediate withdrawal of my muscle, my shoulder immediately spasm. One hour afterward, my collarbone on right side felt like it was being crushed whenever I would take in a deep breath. I had the usual pain in my right arm, couldn't lift my arm over my head due to the immense pain. The next morning at 8:00 am I noticed I couldn't take a deep breath on the right side of my chest. I felt a dull ache on my right side of rib cage, pain level 7. Called doctor and they advised me to get to ER since I was having labored breathing. I arrived at ER at 10:30. They ran tests and ended up sending me home. 3 days later, the pain started to subside. I then developed fever and body aches.
40 minutes after receiving the vaccine, My son complained that his stomach hurt and began projectile vomitting. He then continued to vomit forcefully approximately 2-3 times per hour. This lasted until aproximately 11:45 PM. At that time, he was hungry, and claiming he was fine. No other symptoms before, during or after. When he receives Augmentin, he also will projectile vomit off and on for approximately 12hrs. He never runs a fever nor are there any other symptoms. 12 hrs later he is fine. I did not treat  the vomitting, simply called the pediatrician and spoke to his Nurse at approximately 1:26 PM then watched him closely counting the hours until he was better. When the pattern followed the same reactions that he gets with Augmentin, I then called the Pediatrician the next day (07-27-2010) and spoke with him to report it.
I have received many vaccines in my life and have never had a serious adverse reaction. I noticed the lady gave me the shot very high on my shoulder in the area of the joint. Within hours I had serious pain and could not raise my arm above shoulder height. The pain has subsided somewhat but my range of motion is still somewhat limited. This has been over an eleven day period as of today. I have tried heat and OTC Ibuprofen with little or no relief. I researched these symptoms and found information on "SIRVA". What I've read describes my issue very closely.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). The patient had come to office for a dose of VARIVAX (Merck). No adverse event reported. The patient did not seek medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt reported moderate-severe fatigue, foggy mind, and blurred vision during 15-minute waiting period after receving the vaccine. Nurse who administered the vaccine did not deem it necessary to administer Epi-pen as pt was only experiencing said symptoms. Pt stayed in the store for an additional 45 minutes for additional monitoring. Pt has had double-lung transplant 2x and is on various medications, including but not limited to prograff, prednisone, insulin (short + long), pravastatin, acyclovir
C/O diarrhea, vomiting, spreading rash, fatigue, fever of 100.5 6-14 days post #2 MMR, she reports diarrhea, vomiting some rash post #1 MMR. Labs ordered CBC w/Diff MMR Titer, MRI IgM Consult with clinic ID R/O measles.
This spontaneous case, initially received on 23-Oct-2018 reported by other non-health professional and concerns a 37-year-old, adult female patient. The patient's current condition included multiple sclerosis (MS as reported) (since an unspecified date). On unspecified date in Feb-2018, the patient was administered non-company suspect product GILENYA (dose: 0.5 mg, frequency: once daily and route of administration: oral). On an unspecified date in 2018 (reported as last week), the patient was administered Influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported]. It was reported that, since vaccination, the patient experienced cold. On an unspecified date in 2018, the cold was moved in to the chest. At the time of this report, the patient had not recovered from cold and the outcome of the event (chest cold) was not reported. The reporter assessed this case as non-serious.
my arm swelled up and the injection spot was feverish - broke out in red blotches all over my face - had a migraine headache about hour later - next day was throwing up for several hours and then started running a fever of 101 degrees.
Numbness in left arm to thumb, arm pain around the injection site, Been going to the chiropractor to get adjusted to see if that will help.  Went to the doctor and got steroids and that did not help.  Waiting to go see a neurologist to try and get some relief.  Started at about 60 days after shot and has been going on for about 3 weeks now.
hasn't got 2nd vaccine/ greater than 6 months; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose of Shingrix on an unknown arm intramuscularly on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The patient's daughter stated that her mother had not gotten her 2nd dose of Shingrix vaccine and it had been greater than 6 months. The patient was planning on getting the vaccine. No further information about the patient or vaccine. The reporter did not consent to follow-up. This report is for 2 of 2 patients. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022112808:Same reporter
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown ages and genders. She reported that GARDASIL, PNEUMOVAX 23 (MARRS# 1406USA005479), and ROTATEQ (MARRS# 1406USA005480) were exposed to temperatures outside of recommended range at 30.6F for 36 hours. She stated that the exposure occurred on 23-MAY-2014, and that since then, the unspecified number of patients had received doses of all three vaccines (lot#, dose and route not reported). MMR II was involved. But MMR II did not go out of temperature range in this case. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient returned to clinic Urgent care 30 minutes after receiving vaccines. Complaints of anxiety, nausea and chest pain, patient tearful and rapid breathing. VS WNL noted heart murmur which is not a change for patient. Provider was able to calm patient down and symptoms improved. Patient released with no further treatment with instruction to return to ER if symptoms returned.
Temporary paralysis and numbness in both legs, numbness and weakness in both arms, no grip in both hands. Soreness at injection site.
Swollen axillary lymph nodes, soreness in lymph node area.  Appeared approximately 12 hours post dosing and lasting  for approximately 48 hours
11/19/2010 GMom called stated that child got var & flu shots on 11/17. States child's arm was warm had reddened area palm size. States did not run a fever. States started complaining about 5 pm - c/o mild abdominal cramping, no diarrhea, no vomiting. Thurs (11/18) app good.
Vaccine administration error.  The patient's first dose was on  03/06/21.  The patient came in seven days early for her second dose and it was not caught by the vaccinator.  The patient's 2nd dose was given on 03/20/21.
Patient states that he had severe pain on left arm on the same day where PPSV 23 was administered. Patient states pain traveled down his arm to his fingertips. Patient also describes area as red and swollen. Patient put ice at injection site. Patient states that today, 11/3/16, his symptoms almost completely resolved. Patient declined to be seen by provider in clinic today stating he is fine now.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000892.
(L) outer aspect of arm swollen & painful. Apply ice 5 min every 2 hours IBU or TYLENOL PRN pain & swelling.
Patient hospitalized for pulmonary embolism and COVID-19 infection after COVID-19 immunization. Received oxygen, anticoagulated, and discharged to home.
AT CHECK OUT PATIENT WAS STANDING AWAITING FOR MOM TO CHECK OUT. CHILD PASSED OUT. WHEN I GOT TO THE CHILD HIS HEAD WAS PROPPED AGAINST THE WALL.  HIS EYES WERE ROLLED INTO THE BACK OF HIS HEAD AND HIS BODY WAS JOLTING.  THE JOLTING LASTED APPROXIMATELY 5-10 SECONDS.  CHILD DOESN'T REMEMBER WHAT HAPPENED.
Patient reports a sore arm and feeling unwell starting the day after the vaccine.  The symptoms resolved the following day.  Patient brought the issue up at a scheduled follow up the next week.
CARDIAC ARREST ISSUES; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. 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, batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cardiac arrest issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiac arrest issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230150683- Cardiac arrest issues- The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Information has been received from a physician concerning his 12 month old daughter who was vaccinated with a dose of VARIVAX (Merck) a few weeks ago. The patient was also given six other vaccines along with VARIVAX (Merck). One week after the vaccine being given, the patient developed a zoster like rash on her thigh. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Additional information has been requested.
Tested NAAT positive for COVID 11/23/21 after being fully vaccinated.
next day: light headache, dizzy, fell and injured back and wrist. week later: rash left arm and a little on right wrist
Headache, Myalgia, Arthralgia, NauseaVomiting, cold sweats, left arm red & hurts Narrative:  Other Relevant History:
Patient given booster dose at 4 months instead of 5 months. No adverse effects while in the clinic.  Patient made aware.
Systemic: Hypertension-Severe, Additional Details: reports hypertension persisting since her vaccine, reports systolic readings close to 200, went to emergency room 3 times since vaccine
it is like a measles-like rash; a little bit warm to the touch; it looks like a sunburn; small red dots at closer inspection; a bad headache; a rash on his torso appeared,a rash on his upper back appeared; This spontaneous case was reported by a patient and describes the occurrence of RASH MORBILLIFORM (it is like a measles-like rash), FEELING HOT (a little bit warm to the touch), SUNBURN (it looks like a sunburn), RASH ERYTHEMATOUS (small red dots at closer inspection) and HEADACHE (a bad headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rash in 2019. Previously administered products included for an unreported indication: SHINGRIX (Shingles vaccine) in 2019. Concurrent medical conditions included Allergy NOS. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced RASH MORBILLIFORM (it is like a measles-like rash), FEELING HOT (a little bit warm to the touch), SUNBURN (it looks like a sunburn), RASH ERYTHEMATOUS (small red dots at closer inspection), HEADACHE (a bad headache) and RASH (a rash on his torso appeared,a rash on his upper back appeared). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (BABY ASPIRIN) on 18-Jun-2021 at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 18-Jun-2021 for Allergy, at an unspecified dose and frequency. At the time of the report, RASH MORBILLIFORM (it is like a measles-like rash), FEELING HOT (a little bit warm to the touch), SUNBURN (it looks like a sunburn), RASH ERYTHEMATOUS (small red dots at closer inspection), HEADACHE (a bad headache) and RASH (a rash on his torso appeared,a rash on his upper back appeared) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 120 (High) High.         Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-JUN-2021 and included No new information