chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles- I was given an antiviral to take and topical cream by my dermatologist.  I had a rash that appeared on my right buttocks that hurt and began spreading farther down in a pattern on my rught side into my groin. It was extremely painful and itchy. It caused me to feel tired, nauseous, headaches, an overall feeling of malaise.  I went to my dermatologist 3 days after developing the rash and she put me on the medication. About 4 days later I began feeling better. The rash lasted about 3 weeks. I am still getting a painful sensation every now and then where tbe rash is located.
Red, raised rash around injection site.  Approx 2" square.  Arm swollen in that area.   No other side affects.  Just aware of it today.
Red, raised rash on R arm in the region of the injection site. Painful to touch but not itchy.
admitted 6/23 in status epilepticus. Found to have a basilar artery thrombus
Client received her 2nd dose Pfizer COVID vaccine this afternoon at our offsite clinic by a LPN. Had just asked for a bandaid because there was a spot of blood where she had received the vaccine. Her sister reports she said she was feeling dizzy then her sister turned away and the client fell from standing position to the ground at 1412. Hit on her right side, shoulder and face. Lost conscious momentarily and together with family members we rolled her onto her back. I directed co-worker to call 911. Client came to and we helped her to sit up against the wall. Blood pressure 96/52, P 80 at 1415. Family and client denied history of seizures or fainting. Weather outside hot and client reported she hadn't eaten anything all day. Water provided. Client reported pain from the right side of her face and her lower lip which had a laceration from the fall that was bleeding a small amount. Fire EMS arrived just after 1420. Reported their vitals as BP 110/68, P 97, O2 99%. Ambulance arrived around 1430 and assessed. They had her rise from sitting to standing and reported her SBP dropped to the 70s. Paramedics advised to be assessed in ER. Client left in ambulance at 1443 accompanied by mother. Family provided reassurance regarding syncopal episode and contributing factors. They had no further questions or concerns at time of departure.
2nd day- joint and muscle pain. Injection site pain, soreness and itching. 2nd - 3rd day rash with extreme itching.
Fever; headache; chills; cough; chest discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 15:45 (Lot number: 30145BA) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "chills"; COUGH (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "cough"; CHEST DISCOMFORT (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "chest discomfort". The events "fever", "headache", "cough" and "chest discomfort" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache, chills, cough, chest discomfort.  No follow-up attempts are possible. No further information is expected.  Additional information: Fever, headache, chills, cough, chest discomfort. All lasting now 5 days. The vaccine was administered in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies. The patient had no other medical history. The patient received imaging as treatment for the adverse events. The device date was 03Oct2021.  Follow-up attempts are completed. No further information is expected.
Pt noticed her arm felt tender & noticed in mirror she had large rash at injection site approximately 18 hours after injection; on 5/18/12, pt reported rash was getting better.
pt stated a couple of hours after taking 2nd covid dose she started having vision changes.  Her vision became blurry and hazy.  She had some dizziness and a feeling of being in a daze. On 5/6/21 she woke up w/ mild headache, felt achy, weak and still feeling like she was in a daze w/ blurry vision.  Later that day she developed diarhea, nausea, weakness, body aches and pains.  These symptoms lasted about 12 hours.  The blurred vision, weakness and the feeling of being in a daze lasted about 24-30 hours.  Today 5/7/2021 pt states she feels back to normal with no other symptoms.
Patient received 5 total doses of IPV (polio vaccine) on 4/29/2021; usual dose is 0.5 mL but patient received 2.5 mL.  This was noted on 5/5/21.   The family was contacted and was informed on 5/5/21.   Patient's symptoms following included  headache, croupy cough, increased sleepiness .
Severe sore throat, hard to swallow Monday night 10/15. Aches & pains. Heavy general feeling of sickness and cannot function - fatigue and sleeping all da. No fever (in fact, low). Bad congestion/runny nose. Coughing. Usually healthy - this is quite unusual.
This case meets vaccine breakthrough criteria review. SxS include SOB, chest pain, nasal congestion, cough
pt recv vax 7AUG95 & broke out in full case of chickenpox on 27FEB97;
Immediately Following vaccine: light headed (resolved) & left jaw pain 1 Day following vaccine: nausea, dizziness, headache - all resolved 2nd day following vaccine: fatigue- all resolved 12 days after vaccine: continued left jaw pain- described as consistent dull ache with intermittent "nerve shock", weird taste in mouth, left ear pain feeling full with "crackles".  Patient has not reported symptoms or seen any health care provider since vaccination.
10 minutes after receiving her first dose of the Pfizer covid vaccine, the patient reported that she had numbness on one side of her mouth. She denied any other side effects and felt fine except for noting the numbness. She stayed another 20 minutes and refused additional intervention, requesting to leave with her companion.
I was short of breath. I didn't feel like I could get a deep breath. I had shortness of breath at rest. It kind of felt like breathing through a wet washcloth. Unproductive coughing. Loss of Appetite. I still had sense of smell and taste. I was a little bit dizzy. I have experienced the shortness of breath before in the past but not the dizziness or the loss of appetite before. It felt like I was getting a cold. It felt like if I could have had a productive cough it would have gotten better. But that never got to a productive cough. June 2 - I called the doctor's office and I had figured it would get better and it didn't. I spoke with a Triage nurse and no one could see me that day. And their protocol from what I was telling her was to go to the Hospital ER. She said she wanted me to have a chest X-ray. I went to ER and once I got there and set in the air conditioning for a couple of hours, it felt like my breathing was easier. They took a Chest x-Ray and didn't like what they saw. They took a CT scan and saw it was an old injury  on collar bone so it wasn't the lung. They  gave me an Albuterol inhaler and Singulair. They didn't do any breathing treatment and told me to have Dr. follow up in a week. When I did use the inhaler, it helped greatly with the symptoms and they subsided. I had follow up with the doctor on June 9th, (was still having symptoms and was afraid to uses the inhaler so I hadn't been using the medication properly and he told me to use it.  And later , June 15th, he put me on an additional inhaler and said to use that first and then use Albuterol if needed - as I had started using it too much after seeing him . It was Flovent was the inhaler aerosol. He referred me to have a lung function test to see if it was a problem with lungs or if I needed to see an allergist. I have symptoms but not as bad (using Flovent twice a day). I'm still a little bit raspy sounding when I cough. But my breathing feels a lot freer than it did before.  With medication I am pretty much recovered. Two days to my ER visit - we had pollen counts of 1240 for two days. I was outdoors not knowing the counts were so high. On that third day, I was really short of breath as soon as I woke up.
Fatigue, fever x 2 days.  Then started with constant chest pressure, elevated heart rate which is continuing since first vaccine.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 5:13 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 5:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.    This case was linked to MOD-2021-402935 (Patient Link).
wrong dilutant was used to reconstitute ActHib with no reported adverse event; Initial information received on 30-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (healthcare professional)  This case involves an unknown age and unknown gender patient who used wrong dilutant to reconstitute vaccine HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient used wrong dilutant to reconstitute ACT-HIB with no reported adverse event (product preparation error) (unknown latency). The dilutant used was 0.7 mL of sterile water.   No lab data was provided.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
W/in 5 mi of vax face became flushed, even into hairline, began to itch around neck. Splotchy areas appeared around the areas of itching. P 140, Temp 99.8 @ 215. Given Benadryl monitored TC to MD advised to be seen today by private MD.
OBSTRUCTIVE SLEEP APNEA ACUTE HYPOXEMIC RESPIRATORY FAILURE  2/12/2023 & 1/5/2023 - RECURRENCE OF SAME SYMPTOMS
Diabetes Type 1. Bed-wetting, dehydration, nose bleed, fatigue, unconscious state, excessive sleepiness, excessive urination, rapid weight loss from 250LBs to 165LBs (1 month prior to ER visit).
Extreme joint pain for over three weeks.  Knee joints, SI Joint, inner thighs, and even arms on certain days.  Extreme fatigue.  Mental fogginess.
Patient received 2 doses of the Moderna vaccine out of accordance with the EUA. Patient is 17 and thus is not eligible under the Moderna EUA.
I've had Tinnitus since 2005.  The "noise" was around 3000 Hz at around 70 dba.  During the spring of 2021 I noticed an increase in the volume of my Tinnitus...to nearer 80 dba.  The "noise" increased from around the level of a vacuum cleaner in the next room, to a smoke alarm in the next room.  I'm not sure if the increase was due to the Covid vaccine or because I had Covid in November 2020; but I noticed the increase this spring.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medical history: no. Other medications in two weeks: No. Known allergies: no. Anti-viral details: Product: COVID 19 treatment, Brand: Paxlovid, Treatment start date: 08Jun2022, Treatment stop date: 08Jun2022, Lot number: GA1529, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective cannot be ruled out
8/28/2013 Moderate Other. Patient has had increased cases of shingles since receiving vaccine (3 outbreaks in the last year). He has also had shingles lesions in 2 new locations since receiving the vaccine.
I suffer from RA.  I had my first shot on March 25.  I was scheduled to take my weekly dose of methotrexate on Monday, March 29, but was advised not to take same by my rheumatologist.  By April 5/6, I began to experience symptoms of RA which had been controlled for one year prior to the vaccine.  Pain in both my feet, knees and left wrist.  I also began to experience pain in both my ankles. The symptoms did not subside by the time I was due for my second shot (4/22) but I had the shot anyway.  Again, I had to forego my weekly shot of methotrexate on 4/26. Today is 5/3 and I am still in terrific pain. Today I was prescribed Predisone in hopes of reducing the inflammation.
Brief vasovagal episode lasting a few seconds.  Patient reports faints with all vaccines and needles.  Immediate return to baseline consciousness.
Bruising on (left) upper arm to elbow - lasting 2-3 days warm to touch for 2-3 days. Completely recovered.
Patient had a syncopal episode passed out hit her head and suffered bilateral nose fractures and concussion
High fever (103F), body aches, chills, headache, tiredness, arm soreness/swelling/redness/itchiness at injection site, nausea
area where inject was given was red & swollen & warm & itched; sx remained for 2 days; pt wa treated w/ice packs & APAP;
approx 4hr p/vax pt reported that devel an inj site rxn characterized by swelling & soreness;the swelling extended from axilla to elbow & impaired mobility;w/in 24hr swelling extended below the elbow & the entire area red & hot;sl feb;
Plus multiple lesions of forearm, chest, abdomen, back & legs-seen in office 6/1/04.
This spontaneous report was received from a male patient of unknown age, who was also a pharmacist. Approximately on an unknown date in 2010 (reported as approximately 5 years ago), the patient was vaccinated with ZOSTAVAX (dose and frequency were unknown) subcutaneously. Concomitant medications were unspecified. Approximately in 2010 (reported as approximately for 1 week after the vaccination), the patient's unspecified arm was swollen. The outcome of the event was reported as recovered/resolved (reported as for 1 week). The causality of the event to ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a 42 years old female patient. The patient was vaccinated with a 0.1 ml dose of PNEUMOVAX23 (lot number not provided) intradermally in the forearm on 27-NOV-2012. Unspecified which arm. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported at the reporting time. It was unspecified if the patient had sought unspecified medical attention. Additional information has been requested.
Rash noted on 10/5/11 on both arm mostly in deltoid areas. Mother stated small white bumps that are itchy.
Onset upper respiratory symptoms, allergy like, dry irritating cough, itchy eyes, watery eyes, audible slight wheeze as if in large upper airway. Took Tylenol x3 1 hour apart. Drank lots of water. Allergy symptoms began to wane about 9:00 pm was tired and tiredness persisted through Saturday but no more allergy symptoms. I have had flu shots for many years and have never reacted before except for soreness at injection site. I am concerned that it was the addition of the H1N1. Is that possible? What should I do next year?
(L) arm is swollen at injection site, slightly red and is painful to touch in the underarm region as well as injection site. She was referred to PCP.
Received shot 10-24-13, noticed rash 10-28-13, worse AM 10/28/13 by Tues, PM rash increased noticed facial swelling saw Dr on Wed 10-30-13 treated with steroids - saw allergies 11-5-13.
I had inflammation under my arm.; This spontaneous case was reported by another health care professional and describes the occurrence of INFLAMMATION (I had inflammation under my arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLAMMATION (I had inflammation under my arm.). At the time of the report, INFLAMMATION (I had inflammation under my arm.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-403270, MOD-2021-403277 (Patient Link).
Her arm was tender today; got second shot yesterday 16Aug2021 and was a little tired and felt feverish; got second shot yesterday 16Aug2021 and was a little tired and felt feverish; This is a spontaneous report from a contactable other Health Care Professional.A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 16Aug2021 (Batch/Lot Number: FA7484; Expiration Date: 01Sep2021) as DOSE 2, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On 16Aug2021 the patient experienced got second shot yesterday 6aug2021 and was a little tired and felt feverish. The outcome of event was unknown.