chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored VAQTA lot number N017094, expiration date 31-AUG-2018 (dose and route was not reported) for prophylaxis. No adverse effect was reported. Temperature: 9 grades Celsius to 25 grades Celsius "(10.1 C)". Time frame: 1 hour and 56 minutes. There was no previous temperature excursion involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA003169: Original Case: 1710USA003115, US-009507513-1710USA003166: Original Case: 1710USA003115, US-009507513-1710USA003167: Original Case: 1710USA003115, US-009507513-1710USA003168: Original Case: 1710USA003115, US-009507513-1710USA003164: Original Case: 1710USA003115, US-009507513-1710USA003163: Original Case: 1710USA003115, US-009507513-1710USA003115: Original Case: 1710USA003115.
Flu-like symptoms starting day before probable brief cardiac arrythmia with period of shock.  Taken to ER by paramedics.  Treated with O2, iv saline, iv lasix, iv magnesium with much improvement.  Admitted to hospital for further workup.  Hypercalcemia found.  Patient stabilized and discharged for workup by primary care MD.
Localized erythema and induration (3x4 inches) non tender to palpation.  Dad unsure of onset, first notice but nurse around 2 and seen at the clinic at 4:30. Treatment cool compresses and Ibuprofen.
On 10/29/99, the pt received his first IM-deltoid dose of Lymerix.  A few days later, he experienced redness, swelling, and pain on the entire deltoid. Symptoms worsened over a couple of days, and then resolved within a few days. No treatment was given.  The most recent information received on 1/17/00 reports the condition of the pt is resolved.
I flipped my head over to blow dry my hair. A rush of chemicals flew up my right nostril and a strong  burning occurred for a few minutes. I jumped up and down in pain yellow "OW OW OW" Then it stopped.
i went to sleep and arm was tender. I could not lay on it. The pain woke me up at 4 am. Woke up and seen that arm was hard as a rock and very painful, swollen and warm to touch. Pain is radiating down arm and red Elbow to shoulder. Called the pharmacy and ask what I could do. Advised me to use warm compresses and massage. Around noon I went to the MD and seen the Nurse to place censor in left arm for diabetes and the nurse told me to go get checked out by the pharmacist. Pharmacist advised I call and possibly take some benedrayl. I will be call CDC info to ask about possible medication to take for the upper arm . It is very painful, warm to touch.
Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
In 10/30/01 am mom noticed redness, small bump, swelling by 6pm redness and swelling had increased by 10/31/02. Today 11/01/02 redness increased to 25cm by 12cm L. Benadryl, Keflex 250/5cc 1 1/2 tsp tid.
Patient developed a rash 7 days post injection at the site of the injection.  Patient states that the rash began to get worse over the following days becoming hot to the touch, painful, and somewhat raised as to distort the pores of her skin.  Patient states that the rash is confined to the area of the right arm where she received the injection.  She was advised to contact her primary care provider to see if there was anything they would be willing to prescribed to help alleviate the rash and help her with the pain.  I stated that the only thing over the counter that may help would be topical Cortisone cream and oral Benadryl.  This is day 12 post injection and 5 days since rash first developed.
A mother reported that her 7 month old son received his second dose of Rota Shield along with Hib-Titer, Orimune and DTaP (manufacturer unknown) vaccines on 7/11/99. On unspecified dates beginning in infancy, her son experienced bouts of diarrhea lasting for weeks at a time.
Daughter felt like she was going to vomit and almost passed out. Very sick to her stomach.
pt recv vax & devel a small ticky sz, flat rash under neck & fever of 102.5; also pulled on rt hand like it hurt; No further details were provided;
The patient received Pneumovax 23 on 8/4/21 and on 8/6/21 reports to PCP office and immunization site that she is experiencing hives at the injection, thighs and groin area. Treated hives with Allegra antihistamine cream. After treatment, the hive were no longer raised and itchy. Denies SOB or difficulty breathing. Instructed patient to follow up with physician and if experience shortness of breath or difficulty breathing to go to the emergency department.
@1130 Pt complained of feeling "funny" in her throat. Pt stated that she feels like her throat is dry. Water provided. Pt stated that it didn't improve. Pt stated that its hard to swallow. Called Dr  about pt's symptoms. TORB for Benadryl 25mg PO x1 stat received. Gave Benadryl 25mg PO given.    @1140 Pt complained of worsening symptoms. Pt stated that her voice changed. Clear speech with some hoarseness. Told pt that we will need to bring her to the ED for further care and evaluation. O2 97%RA, HR 86. Airway patent. Clear speech with  Pt agreed. Team alert called. Gave report to RN OBGYN and to ED nurse.
My blood pressure, which normally runs low, dipped very low (85/55); I had pretty severe brain fog.  I never blacked out, but I was concerned I might.; This is a spontaneous report from a contactable consumer reporting for himself.  A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via an unspecified route of administration on 23Jan2021 on right arm at single dose for COVID-19 immunization. Facility type vaccine was at hospital. Medical history included small fiber neuropathy, dysautonomia/vasovagal syncope, ineffective esophageal motility disorder, migraine, GERD, allergic to preservatives in many eye drops, but never a vaccine; allergic to dust mites. Concomitant medications included nadolol, midodrine, esomeprazole magnesium (NEXIUM), amitriptyline and other unspecified medications. The patient stated "My blood pressure, which normally runs low (I have dysautonomia/vasovagal syncope) dipped very low (85/55) and I had pretty severe brain fog. I never blacked out, but I was concerned I might." The reported events happened on 25Jan2021 18:00, and resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events were resolved in 2021.
About two weeks after the 2nd dose I woke up with fever and chills around 1AM. I stayed home with muscle aches and joint paint. Around 11PM that night I had a flare up of my interstitial cystitis. This causes pain and urgency while I urinate and I have constant frequency. I had a lot of pelvic. I was still having pain on April 2nd and honestly had bilateral foot and hand pain and knee pain down into my ankles and feet. I had hip pain start as well and just pain in my joints which lasted about eight weeks where it was severe and then it has gotten better but has not gone away completely. I had a telehealth appointment with my urologist and we set up an instillation because we had upped my medication for my Interstitial cystitis flare up. However I did not get the instillation because the pain had gotten better and I was able to return to the medication two times a day rather than taking that extra third dose.
taste buds  seem to be not working as well as before, no treatment, hope they come back.....any info you can add?
No side effects happen to the patient, no fever, just redness and swelling at the vaccine site lasted for days and did not require any treatment
Severe hives developed and would not respond to over the counter treatment of antihistamine (Zertex) and topical Cortizone-10, so I went to the hospital and was prescribed Prednisone 20MG (3 tablets for 5 days).  It has cleared up my hives, but I am still using Zertex daily to control some itching symptoms.
Tinnitus - ringing in my left ear and right ear.  Started around the time of the first shot, got worse (much louder) after 2nd shot.
headache; fever; arm was swollen; arm was achy; arm was tender; tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), PAIN IN EXTREMITY (arm was achy), TENDERNESS (arm was tender), FATIGUE (tired) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), PAIN IN EXTREMITY (arm was achy), TENDERNESS (arm was tender) and FATIGUE (tired). On 27-Apr-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (arm was swollen), PAIN IN EXTREMITY (arm was achy), TENDERNESS (arm was tender), FATIGUE (tired), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 99.3f The patient had fever.. On an unknown date, Body temperature: 100.2f and 99.7f.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Crosslinked with MOD21-082836
On the 2/22/ 21 I discovered itchy red bump like a bite on left side under arm.  It really itched and I put some bug bite non itch cream on it. Next day more red 'bites' going up and across top of breast.  also many little red bumps appeared aroud initial 'bite'.  Was able to see Dr. that Friday  2/26/21 where it was diagnosed as shingles.  Given medrol dose pack for 6 days and famciclovir 500 mg tablets tid for 7 days.  Rash started to improve immediately and finished all medications in time for my 2nd covid-19 vaccine.
Thymoma - Median Sternotomy and Thymectomy -  had a short stay in ICU for post operative management and was started on her Anti HTN Meds; Chest Tubes were removed without any complications and was discharged home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Case number PHEH2013US026017 is an initial spontaneous report received from a pharmacist on 13 Dec 2013. This report refers to a 50-year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: 13464P) intramuscularly on 13 Dec 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 Dec 2013 at 6 pm; at 08:55 am on 04 Dec 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 Dec 2013 at 5 pm. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
A  few months  after receiving the vaccine, I began ovulating (I'm 68 y/o). I know what it was because I used to do the ovulation method birth control and charted my cycles for more than 10 years. I began menopause when I was 54. This time, I touched the discharge once and noticed the tacky texture, then a few days later it became like egg white. Several days later I had a light period that lasted about 4 days. I was on HRT at the time. I reported this incident to my doctor and went in for an exam. She said everything looked healthy inside, and the tests for cancer (or whatever) came back negative. She advised that I go off HRT, that it wasn't meant to be taken for the rest of my life, so I did. I'm having hot flashes now, and have had only that one period, nothing else so far. I'm a very healthy person, and not concerned about that anomaly. In fact, I thought it was kind of cool.
pain on the back part of my shoulders. Excruciating, worst pain; she could sleep at all, she wasnt able to have food, she also had no motivation to do anything, not wanting to do anything, not wanting to leave her apartment; shooting pain on the right side into ear. It feels like her ear was being ripped off; shooting pain on the right side into ear. It feels like her ear was being ripped off; Lack of motivation; I had a terrible pain in my neck on both sides, I really couldn't move my neck; didn't have any appetite; body felt strange; This is a spontaneous report from a contactable consumer (patient). This 79-Year-old female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via unspecified route of administration, administered in Left arm on 04Feb2021 as a single dose for COVID-19 immunization. The patients past medical history and concomitant medications were not reported.  On Friday 05Feb2021, the patient felt like her body didn't feel good, like she was not tired or exhausted but just a strange feeling. Then following Saturday Sunday Monday and Tuesday she was okay. Then on Wednesday 10Feb2021 almost a week later, she got up with excruciating pain in the neck, she did not have a temperature, and she did not lose sense of taste or smell, as well as she had no appetite. She had no Appetit on Wednesday 10Feb2021, Thursday 11Feb2021 and then on Friday 12Feb2021 she finally ate. Every time she would move her body its like the entire neck, shoulder, and shoulder blades were in excruciating pain. She could sleep at all, she wasnt able to have food, she also had no motivation to do anything, not wanting to do anything, not wanting to leave her apartment. A week later then on Saturday and Sunday, on Sunday her neck hurt. Both Sunday and Monday last night she was in excruciating pain, that was in the neck and was trying to sleep. She could not turn from one side to the other, because of the shooting pain on the right side into ear. It felt like her ear was being ripped off. Today her ear felt strange, she could hear but soft and that part of neck on the right side was not the same. She had no Tylenol or anything because she did not want it to effect the vaccine. On an unspecified date, she had lack of motivation. Her second dose was scheduled for 25Feb2021. Caller asks could she get side effects at any point.  The patient was asking if her symptoms after her first dose were normal. The Clinical outcome for all the events was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. Concurrent conditions or medical history were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored oral, ROTATEQ (route of administration default to oral, dose, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to Medical Center ED on 4/1/2021 with complaint of 2 day history of bilateral upper and lower extremity weakness that is increasing. Patient had received Covid vaccine 12 days ago and had a self-limited 3 day diarrheal illness 1 week ago. Admitted to hospital, diagnosed with Guillain-Barre, and has undergone plasmapheresis. As of 4/8/2021, patient is showing signs of improvement with movement of his lower extremities.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of (Oka-Merck) PROQUAD (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of (Oka-Merck) PROQUAD: lot# L002419 with expiration date 23-JUL-2016 or lot# L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
approx 40min p/vax had onset of swelling lower lt side lip;no airway compromise;DPH & epi given;
SM with h/o eczema that received SPV and had exacerbation of his eczema.  His concern is more focused on his children at home, 2 of whom have more severe eczema.  Erythma Start: 12/2007 Lesions, patch Start: 12/2007
This spontaneous report was received from a 59-year-old female patient who reported on herself, via a company representative. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, approximately in March 2017, (reported as about 2 months ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prevention of shingles. On an unknown date in 2017, reported as shortly after receiving ZOSTAVAX, the patient experienced leg pain, joint swelling and was diagnosed with inflammatory arthritis. On an unknown date in 2017 (reported as "during the diagnosis work up"), the patent had rheumatoid factor test performed with negative result. It was reported that the patient experienced significant disability in that she was unable to exercise due to pain in her joints. An unspecified treatment was provided for the adverse event. No product quality complaint (PQC) was involved. The outcome of the adverse event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the patient did not give consent to contact her physician.
in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event; She mentioned that they received the vaccines with no adverse event; Initial information was received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA342577.  This case involves 4 patients an unknown age and gender patient who experienced in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event and mentioned that they received the influenza quadrival A-B vaccine [Fluzone quadrivalent] with no 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 received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and was in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event (product storage error) (unknown latency) and she mentioned that they received the vaccines with no adverse event (poor quality product administered) (Latency: same day)  The information on the batch number was requested.  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.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On JUN-2017 the patient was vaccinated with ROTATEQ lot # M019708, oral for prophylaxis. On JUN-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1709USA003223.
On the day of my vaccine I had typical symptoms - chills, fatigue, and headache.  The next day I felt better, just tired.  On Tuesday the 23rd I returned to work and felt fine, but I did have an occasion of dizziness and I was tired.  I felt good on the 24th and returned to life/exercise as normal.  I woke up on the 25th in the early morning with a strange sensation in my head.  (I described it to my husband that it felt like I had worms in my head.)  When I got up I experienced dizziness that seemed like vertigo.  I tried to proceed with my day, but I got an intense headache, loss of appetite, and sore upper leg muscles.   I reached out to my doctors office.  I saw a doctor on the 26th.  (My dizziness was better, but I still had a headache and muscle aches.)  We discussed vertigo and possible reactions to the vaccine.  He also found some liquid in my ears and so we questioned allergies.  I got allergy medicine and took it when I got home.   The next day in the early morning the headache and muscle aches returned and I called a hotline through my doctor's office.  (The headache was quite intense.)  I spoke with a nurse - I was concerned that I may have Covid.  We discussed my reaching out to get a test if my symptoms were not better by Monday.  By Sunday I was feeling a bit better.  My headache had improved but I still had muscle aches in my legs.  I determined I would be able to go back to work on Monday.   The last symptom to remain was aches in my legs.  On Wednesday the aches were in my upper legs , by 3/30 the aches were in my ankles.  I was feeling better by early April.
Case number PHEH2014US025062, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 52-year-old male patient. historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 01 Dec 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree D during the excursion. No adverse event reported following this medication error (incorrect storage of drug).
Patient presented with shortness of breath; fever; felt tired; Vitamin C; Folic Acid; Multivitamin with minerals; Zinc; Tylenol; Inpatient
Headache, cough, Fever 99.9, wheezing, body aches, fatigue