chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
The patient reported no side effects while waiting the required 15 minutes post vaccine.  The patient also reported no side effects per phone call 1 and 1/2 hours post vaccine.
Fever 101 all day, tried Aleve to deal with the flu-like symptoms. On 3/7/2021 had lightheadedness, arrhythmia, and palpitations. General lab work and test done by attending ER cardiologist and found it was most likely a reaction to the vaccination. No treatment or prescription was issued. Followed up with own Cardiologist visit. Confirmed all normal.
administered only the liquid portion of menveo, not the powder component; administered only the liquid portion of menveo, not the powder component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa465a, expiry date 20th September 2022) for prophylaxis.   On 26th July 2021, the patient received the 2nd dose of Menveo. On 26th July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that, 16 yrs old patient was administered only the liquid portion of menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Received vaccines at 4:30 PM. Pain in left arm started at 5 PM. Reports aching and burning throughout night. 5 AM 11/11/03, client went to ER with complaints of severe pain in left arm. Continues to complain of severe pain 11/19/03. Was treated with IV fluids, Demerol, Nitro. Rx given for Lortab and Protonix.
COVID Breakthrough. Patient had some altered mental status and fever starting on 11/16/21. He presented to the ED on 11/18/21 with hypoxia and tested positive on 11/18/21.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 6/22/2022 DIASTOLIC HEART FAILURE, ACUTE  HYPOXIA 6/30/2022 DIASTOLIC HEART FAILURE, ACUTE  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 6/22/2022 BACTEREMIA  HYPOXIA 6/30/2022 BACTEREMIA
heart palpitation started couple minutes after the shot, last for couple minutes. couple hours later, left leg felt expanding, numb, legs felt uneven. vomit at lunch next day, and felt nausea got zofran , HA , brain fog, fatigue. Day 3 woke up with chest tightness, stayed in bed almost whole day, heavy cycle came on day 3 afternoon with lots PMS. I had  IUD, heavy cycle and PMS is not expected. Spent 5 days in bed after 1st shot. Got 1 wk break, cycle started again and became heavy after 2nd shot. Similar, but more severe symptoms after 2nd shot, my legs still felt uneven, and continuously frequent HA
Significant Swelling and redness with itching.  NOTE - small amount for a day or so, then went away, reappeared two days ago much more pronounced
Pt presented to the vaccination site on 11/08/21. The client notified RN after 1-2 hours after receiving his second dose he felt like his heart was racing. The client went to the emergency room and they kept him in observation for 4-5 hours. They did not give him any medications. Client stated that he was then sent home. Client stated that the next day he felt the same symptom of his heart racing and returned to the hospital. Client stayed at the hospital in observation from 1100-2100 that day. Client stated that he felt his hear racing on and off the entire time. Client was sent home after staying in observation for 10 hours. Client was not given any medications. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID Moderna booster vaccine. Approval to proceed with COVID vaccine Moderna booster with 15 minute observation was obtained from medical consult team, Vaccine Operations Lead, RN via text message. Client received COVID Moderna booster vaccine Lot# 066F21A on 11/08/2021. The client did not report any symptoms during the observation period. RN educated client on worsening signs and symptoms of COVID vaccine and when to seek EMS, urgent care or when to return to ED if symptoms return. Client verbalized understanding. The client left the vaccination site at 1415.
Hosp 3/14/07 for seizure observed by mom 05/15/07-records received from facility. 2 month old with cluster of short paroxysmal episodes consistent with generalized tonic-clonic seizures in otherwise healthy infact with no neurologic or developmental issues. If true seizure probably related to DTaP given 2 days prior to admission. Seizures otherwise isolated and patient would be unlikely to have long term sequelae. Monitored overnight for seizures.
Patient fainted immediately after receiving vaccine. Fell from sitting position to floor. LOC for approx. 30 seconds. Then awake with no memory of prior event. Had red, raised, quarter-sized bump on left forehead from hitting floor.
slight urticaria; This is a spontaneous report from a contactable physician.    A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, the patient also received methylprednisolone sodium succinate (SOLU-MEDROL) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported.  The patient previously took steroid antibacterials. The patient experienced slight urticaria on an unspecified date. The caller inquired whether Solu-Medrol Act-O-Vial contain polyethylene glycol. Caller stated a Covid vaccine (unknown manuf.) "might" have been administered to a patient who then had slight urticaria possibly due to the PEG component. Hypothetical patient also had allergic reactions to "steroid injections". Patient now needs an injection in her knee and caller is evaluating use of Solu-Medrol. The outcome of event was unknown.  Caller did not wish to report to safety and cited this patient as being "hypothetical". Documenting available information.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
C/O FATIGUE AND FEVER 38 DEGREES CELSIUS; RECURRENT FEVER X 48 HOURS AFTER INITIAL ONSET IN PM.
This case meets vaccine breakthrough criteria review.  SxS 2 days of weakness, fever, cough, sore throat, vomiting, dysuria.
Lymphedema   Antibiotics NSAID?s, lab work to be drawn on 11/1/2021
Information has been received from a RN concerning a 5th grade male student who on 11/26/1996 was vaccianted with a dose of varicella virus vaccine live. In mid December he developed Chickenpox in mid December of 2004. According to the school nurse 58 other elementary school students who developed chicken pox and 34 of them had previously been vaccinated with a dose of varicella virus vaccine live. Unspecified medical attention was sought. There was no information regarding the present status of the student. No product quality complaint was involved.  Addition information    has been requested.
Marked viral cellulitis-8 cm after receiving the smallpox vaccine in the Left arm
Patient's wife reported via telephone conversation with current nursing staff that patient had presented outpatient this morning around roughly 10:30AM, where he received his Covid-19 vaccination. He then went grocery shopping with his wife, and presented to home, where he began having notable difficulty swallowing and increased confusion, family had then sat him down in living room chair, where his daughter noted acute onset of tongue, upper/lower lip swelling, and right eye drooping. Patient's wife reports that he typically manages all of his home medications by himself, and manages his own ADL's without assistance at home. She reports that he did miss his noon dose of Sinemet, otherwise he has not missed any doses of current prescribed medications, and denies any recent start/change to current medication regimen, or OTC medications. Patient had difficulty swallowing scrambled eggs
My eyes were red and itchy. My face was itchy and red. I took Benadryl.
I have been having left arm pain every since having the vaccine. I thought it would go away but the discomfort is now when I have Range of Motion upward and the discomfort is in my shoulder, arm area and a little below the injection site. I still am having that discomfort and in addition to that, that past 7 days I have been having neck and jaw pain like in the node areas front and back of my next. As well as my lower lip has has two episodes of swelling but it goes down and then it feels ok. I generally overall just don?t feel well.  Eye and head pain as well.  I thought it was best that this be reported cause I just don?t know what is going on. I have made an appointment with my doctor which is on Feb 5.
Vaccine administered. Pt. called 25-30 minutes after he left clinic. Pt. said his chest was tight and he had a little difficulty breathing. Pt went to Dr's office about five minutes away. Pt was treated for an asthma attack and released.
After about 5 minutes, patient called to me and said she was having breathing difficulty. She had a red face. After I got to her, her breathing continued to worsen and she was gasping for air with her head tilting back. Her face got very red. My intern, called 911 and retrieved an EPIPEN so that I could administer. I gave her 0.3mg EPIPEN and she did begin to breathe normally and intern and I took turns waiting with her until ambulance arrived and took her to the ER at hospital.
I received the shot around 0730 on 12/30/2020. Went home and got ready for work. Around 12am 12/31/2020 my arm started to radiate at the injection site and was very tense. I placed a heat pack on the right harm but the pain did not dissipate.  My arm continued to be in pain for the rest of the night. Around 0240 I ate dinner, had water and still had some arm pain. Around 0345 my arm started to flare up and sent pain sensations throughout my body. My right arm was increasingly discomforting, I could barely move it. The sensations spread to my legs, numbing them and my throat had felt as if it were closing up. I got up to get the attention of the nurse and was able to flag her down. She said I was pale as a ghost. My vision was very blurry, I could not hear anything because my ears had filled up and everything was muffled. My head had begun to ring and I was on the brink of fainting when a chair was given to me. My eyes had become extremely sensitive to the light, I was given water and spoken to about what had happened leading up to the event. I was greeted by the paramedics who drew my blood, placed an IV and transferred me to the Acute Care portion of the Emergency Department. My vitals were 76/49, 80/50, 90/56, 100/60 before being brought to the ER.  On 1/1/2021 My thighs have been sore/tense, my knees and ankles have been stiff and just feeling sickly. On 1/2/2021 much of the same symptoms are present. The soreness in the muscles isn't as prevalent, however joints still are stiff On 1/3/2021, congestion and runny nose are still present, stiffness in ankles and now shins are prevalent.
Rash initially on right calf, then left calf and both thighs, starting on posterior and moving to lateral and finally around knees. Then later in evening both arms especially forearms top side. No real rash near injection site itself.  The rash was either or both burning or itchy, with some scaly areas outlined in white which looked much like very very dry skin.  The were no apparent rash areas on stomach, chest or back.  Took a 180mg antihistamine (fexofenadine) prior to bed to quell the itch. Applied Vaseline Intensive Care Hydration lotion to areas.   Morning saw some relief in rash redness, but by 10:30 am  Sunday itch has returned.
I experienced upper respiratory tightness, diarrhea, chills, wheezing, cough, bronchitis and fever.
None, gave combo vaccine to child age 6 5 dose of Dtap, 3rd dose Hep B, 4th dose IPV to avoid so many pokes.
Red patch on her arm; A report was received from a consumer concerning a 32 year old female patient who was participating in the mRNA-1273 trail and developed red patch on her arm.   The patient's medical history, as provided by the reporter, and relevant concomitant medications were not reported.   On an unknown date the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient developed a red patch on her arm beginning on an unknown date.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event red patch on her arm was not reported.  Reporter causality for the event was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient had stiff neck in arms of 8/15/02. Took Tylenol and taken to college by parents that day and participated in color guard twirling, rifle and saber. Has continued to participate in all activities. No medical attention sought. As of 9/16/02, still has stiff neck, hurts to look up. Mom and patient sure discomfort from Menomune.
Pain in shoulder, shoulder blade and arm pit. Fever 101.1. Red welts, quarter size, from injection sight forward to arm pit then diagonally from armpit across bicept aft. These all happened in the left arm (pneu vaccine).
Pt admitted on 6/8 for cellulitis after receiving second dose of vaccine on 6/2. Per guideline, all hospitalizations are to be reported.
PT STATED HEART RACING, INABILITY TO SLEEP, INABILITY TO UNWIND 12 HOURS AFTER RECEIVING VACCINE.
Within less than an hour I began to have more than normal pain in my arm and by the next morning it was significant. I began to realize it was not so much in my arm but in my shoulder and I began having trouble lifting my arm. The pain and mobility issues increased over the next 5 days to the point where I could barely touch my head. The pain and mobility issues have decreased to a certain extent but I am still in significant pain and struggle with certain movements.
Mom states that patient feels faint.  Pale, cool to the touch a few minutes after vaccination.  States her eyes were blurry.  Pulse=98.  Relief with rest, drink of water.  Pulse=88 at 4:55. Advised reporting to MD.
Information has been received from a health professional concerning a 16 year old female with pollen allergy, house dust allergy and mycotic allergy who on approximately 12-AUG-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included mometasone furoate (NASONEX), budesonide (PULMICORT), loratadine and levalbuterol hydrochloride (XOPENEX). On approximately 12-AUG-2007 the patient experienced throat swelling, tongue swelling and became congested following vaccination. On 13-AUG-2007, the patient sought medical attention during an office visit. The patient was treated with diphenhydramine HCl (BENADRYL) and an unspecified inhaler. Subsequently, the patient recovered from throat swelling, tongue swelling and became congested. The reporting nurse considered the patient's throat swelling, tongue swelling, and congestion to be immediately life-threatening. Additional information has been requested.
patient got very dizzy, with an almost "grey" color to skin. She had not eaten anything before vaccine. Given a coke to drink by dad and monitored for 15 minutes. Patient had full color back when she left and felt so much better
Extremity pain, swelling and redness.  Patient called after hours spoke with nurse from hotline at hospital.  Reaction was in left thigh.
This is a spontaneous report from a contactable consumer reported for mother and contactable consumer reported for herself. A 93-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9267; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 12Feb2021 14:00 (at the age of 93-years-old) as DOSE 2, SINGLE for covid-19 immunisation at other facility. Patient was not pregnant at the time of vaccination. Medical history included high blood pressure, acid reflux disease from an unknown date and unknown if ongoing. Concomitant medication(s) included valsartan (VALSARTAN); omeprazole (OMEPRAZOLE); calcium (CALCIUM); colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously took CLEOCIN [CLINDAMYCIN HYDROCHLORIDE] and experienced allergy. The patient previously took first dose of BNT162B2 (Batch/Lot number: EL3247) in right arm on 22Jan2021 16:30 (at the age of 93-years-old) for covid-19 immunisation and experienced feeling washed out. The patient experienced high blood pressure, feeling very washed out as well on unspecified date in Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: 171/91. The event was stated as not serious. Three days after the second injection her blood pressure spiked on 16Feb2021 (reported as today) at 171/91 and feeling very washed out as well. No other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
On 11-1-05 at approximately 2000 employee got a localized rash on her arms. She then developed a sore throat, sinus drainage and body aches. She was off of work on 11-4-05 due to her symptoms. She remained afebrile. Today the symptoms have somewhat subsided and she only has a sinus congestion and pressure. No rash or fever.
On 11/21/11: Pt. presented with area 2"x4" on (L) arm on deltoid that was red, swollen and warm. Pt. stated arm started hurting in evening 11/.18/1. On AM 11/19 had headache and arm aching. On 11/19 had shaking, chills, fever and vomiting. Began improving on 11/20 in PM. Took a couple doses of TYLENOL and BENADRYL with little improvement. Saw OB/GYN today and he suggested warm compress. Recommended TYLENOL/BENADRYL TID x 2d and to see MF if no improvement in 1-2 days.
The pt developed a "fibrous tissue (lump) on anterior thigh, secondary to immunization. Received immunizations 1 month prior to ER visit.
Ten days  after the first shot and four days after the second shot I experienced two episodes of chest tightening, increased heart rate, and pain that radiated around to my back. Each episode lasted about 15 minutes. During the second episode, I checked my heart rate on my watch. It was 110+.(I forgot to do it the first time) Both times I was sitting down doing a jigsaw puzzle . Not exactly stressful or physically taxing.
4/6 woke w/bad headache, dizzy, r. side paralysis, dragging r. leg, had difficulty w/speech. Called 911, went to ER via squad w/stroke like symptoms. Tests, no sign of stroke, no known cause, ok to go home. 4/22 paralysis symptoms recurring, called 911, ER via squad, stroke like symptoms. R. side paralysis, tests no stroke, admitted, no knowm cause, referred to nuerology, ok to go home. 4/29 seen by nuerologist, no known of cause, treated for migraine w/o pain, trans. neuro. defecit. Intractable migr.w/aura w/status migranosus. Ongoing/continued episodes, r.side paralysis. 4/30 2nd dose COVID vaccine. 5/14 episode started in AM, cont. on/off, started around 2pm, r.side paralysis, facial droop, cont. 5 days perm weak
Patient requested to receive the Pfizer Covid vaccine in October.  He said he hadn't had any doses of any other Covid vaccines so this would be the beginning of the series.  When he came back 3 weeks later to get the second dose of the Pfizer series it was discovered in his file that he had received a dose of Moderna in April.  So he should have received the second dose of Moderna in October, not Pfizer.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a female patient who received BEXSERO (batch number 16B701A, expiry date 28th February 2019) for prophylaxis. On 21st August 2018, the patient received BEXSERO. In August 2018, less than a week after receiving BEXSERO, the patient experienced injection site erythema, nausea, injection site induration, injection site discoloration, rash, blotchy rash, erythematous rash and skin warm. On an unknown date, the outcome of the injection site erythema, nausea, injection site induration, injection site discoloration, rash, blotchy rash, erythematous rash and skin warm were unknown. It was unknown if the reporter considered the injection site erythema, nausea, injection site induration, injection site discoloration, rash, blotchy rash, erythematous rash and skin warm to be related to BEXSERO. Additional details reported as follows: The age at vaccination was not reported however it could be 18 or 19 years old. The patient had developed injection site reaction that includes red, hard site about 4 by 6 cm with space of white skin and then blotchy red rash that is warm to touch, all on upper arm on site of injection. The patient also had nausea and had an area of rash on chest that was 2 by 3 cm but not warm to touch and an area of rash on the back that was 3 by 4 cm and not warm to touch.
4 days after receiving my first dose of the Pfizer vaccine I was admitted to the hospital with sever me abdominal pain and diagnosed with appendicitis. Surgery was required to remove my appendix. I had no symptoms prior to receipt of the vaccine.
Second dose given 2 weeks apart; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 2 weeks apart) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 2 weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 2 weeks apart) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
After 2nd booster (April 14 2022) of Moderna vaccine, experienced breakthrough COVID 19 infection. Diagnosis was on 5/4/2022