chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joint discomfort; Swelling of hands; Swelling joint, fingers, feet and knee; Swelling joint, fingers, feet and knee; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 via an unspecified route of administration on an unspecified date for covid-19 immunization. On an unspecified date patient experienced joint discomfort, swelling in the hands and swelling joint, fingers, feet and knee. Patient asked if that is a normal side effect. Patient was informed about the Pfizer medical department. Patient said she will call them and now just concern about her husband side effects. The outcome of the events was unknown.  Follow-up attempts are possible. Further information is expected.
After giving the patient the vaccine, we realized that we had drawn up the vaccine from a vial that had been punctured approximately 16.5 hours prior.  Moderna vials are only good for 12 hours after being punctured.
That evening severe myalgia and very cold followed by severe feverishness all night (did not take temperature). ON 10/10 AM  dark brown and red urine probably hematuria (call doctor to get seen)
Red (L) forearm, (L) fingers painful and purple, (L) upper arm and shoulder swollen. 12-23-16 swelling almost gone; fingers pink and no longer painful; feels fine; almost resolved.
Patient described having a red, raised and itchy area the size of a baseball around the injection site. The patient contacted their primary provider and they recommended ADVIL 200 mg twice a day and ZYRTEC daily.
Redness, tenderness, swelling, inflammation to include hot to the touch, peeling, arm pain x4 weeks. Patient prescribed antibiotic.
At 1 AM on 4/3/21, I got up to take some Tylenol since I woke up feeling like I had a temperature.  I walked to the kitchen (which isn't very far) and had an extreme feeling of overwhelming weakness and fainted. (only fainted one other time in my life).  I hit my head and eye and now have bruising from my hairline and down my cheek on my right side.  My eye and eye lid are  black and blue.  I had 101 temp and chills and body aches.  Immediately starting vomiting and had diarrhea for 6 hours.  Had a temp of 100 the whole day of 4/3/21.  Then 99.5 on 4/4 and 4/5/21 and still tired and achy.  By 4/6, I felt better.  Although my symptoms were just a few days, I would have never taken the second Moderna shot, in hindsight.  In fact, lots of people I know have had strong reactions to the second Moderna vaccine.  I have to say I have never gotten so sick so fast in my life.  No way to fight it - I felt took weak and vulnerable.
7 hours post vaccine, I had very runny nose, thick clear  mucus kept coming out of my nose. I felt feverish although my temperature is within normal limits. I had a mild headache and very sore arm on the vaccine site, body aches and malaise which I know are part of the list of side effects I would experience post vaccine, but then about midnight, I developed a huge rash or hive near my left armpit. Then, on Sunday, 12/20/2020, more big hives appeared on my body and my left hand is very itchy and the palm looked red and more swollen than my right hand. I took some antihistamine and notified my doctor via an e-mail. He told me to take diphenhydramine 50 mg every 6 hours. The hives are still present and much bigger and appear in more areas of my body.
pt recv vax 16APR98 945AM & devel erythematous patches on forehead p/crying ?rxn to vax-probably not;
Our office was closed on 10/22/03 so pt didn't report until 10/23/03. C/o of redness and swelling at injection site. Denied fever. Told to ice arm and take Tylenol.
Delayed local hypersensitivity reaction; big large goose egg-size, light to medium pink,little bit swollen; big large goose egg-size, light to medium pink,little bit swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (Delayed local hypersensitivity reaction), VACCINATION SITE SWELLING (big large goose egg-size, light to medium pink,little bit swollen) and VACCINATION SITE ERYTHEMA (big large goose egg-size, light to medium pink,little bit swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa, Clindamycin), Sunscreen sensitivity, Insect bite allergy and Drug allergy (Clindamycin). Concomitant products included CALCIUM ACETATE (CA P) and VITAMIN D NOS for an unknown indication.   On 13-Jan-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 12:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE SWELLING (big large goose egg-size, light to medium pink,little bit swollen) and VACCINATION SITE ERYTHEMA (big large goose egg-size, light to medium pink,little bit swollen). On an unknown date, the patient experienced VACCINATION SITE HYPERSENSITIVITY (Delayed local hypersensitivity reaction). On 26-Jan-2021, VACCINATION SITE HYPERSENSITIVITY (Delayed local hypersensitivity reaction), VACCINATION SITE SWELLING (big large goose egg-size, light to medium pink,little bit swollen) and VACCINATION SITE ERYTHEMA (big large goose egg-size, light to medium pink,little bit swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information has not been provided.   This case was linked to MOD-2021-082652, MOD-2021-082652 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Reporters Address, Email Id provided.Patient information provided.Concomitant medications(sulfa, clindomycin, some skin product, sunscreens, insect bites) provided. Outcome of the event information provided.Outcome of the Follow up-1:The reported events were resolved on 26-JAN-2021.
Mother brought child to ER on 8/26/2008 because child appeared very sleepy since receiving DTaP on 8/25/2008. The mother also stated that --
MDV Polio (Ipol) that was exposed to a previously reported temperature excursion; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient an unknown age who was vaccinated with IPV (VERO) [IPOL] (Lot P1A171M, Exp date: 24-Apr-2020) vaccine which was exposed to higher temperature.   This case is linked with cases id -2019SA139565, 2019SA139568, 2019SA137200.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to Incorrect product storage.  Vaccine stored at temperature outside the recommended range. Vaccine stored at temperature outside the recommended range (Ipol) that was exposed to a previously reported temperature excursion and was given to patient).   It was not reported if the patient experienced any adverse event following vaccination.  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 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.  List of documents held by sender: none.
Child dosed with expired (12-8-10) ROTATEQ oral on 12-28-10 per Dr. instruction parent called to bring child for redose on 1-28-11 (4 wks after invalid dose).
I read that PROQUAD vaccine is prescribed for children between 12 months and 12 years. Can it also be used for adults; This spontaneous report was received from a company representative concerning an adult patient of unknown age and gender. No information pertinent medical history, concomitant medications or drug reactions/allergies.     On an unknown date, the patient was vaccinated Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (dosage schedule, anatomical location, route of administration, lot number and expiration date) (product administered to patient of inappropriate age).
Information has been received from a physician concerning eight patients who in 1995 were vaccinated with one dose of varicella virus vaccine live (lot 608582/0410B). Three to four years later, the patients experienced attenuated chicken pox. The physician expressed a concern regarding the lot number. The physician noted that the vaccine was stored properly. The physician noted that half of the attenuated cases of varicella were from lot 608582/0410B which represented only about 5-10% of my varicella vaccine total doses used in the last 5 years. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional patients were reported with adverse experiences following vaccination with varicella virus vaccine live (WAES01032473, 01071647, and 01071649).
Received shot for over 65 yo on Oct. 19 around noon. A couple of hours later about an inch below injection site arm itched, swelled and burned. It spread down my arm toward my forearm at 5pm I returned to show to med staff it was oval shaped hot sore swollen area to the other side of my elbow. The next morning I returned to our occupational health department and had it looked at again. The size the swelling had increased and was spreading around the inside of my arm the PA drew with marker on my arm to see if the swelling would continue to grow. It overlapped the boundaries the next morning but wasn't quite as hot as before. I assumed it was getting better. It remained swollen over the next week or so but gradually went away. The third day after the shot. Saturday October 22, 2016 I started to feel like I was coming down with a virus or a cold. My throat was sore, my ears itched and I felt congested. By Sunday morning I was too sick to do anything but sleep. My head and chest were completely congested and I had a fever 101. I felt like someone was sitting on my chest. I couldn't cough anything up but found breathing more difficult than usual. This lasted Sunday, Monday, and Tuesday. The fever went down so I went back to work Wednesday October 26. The coughing and nose blowing began and I still have it today, November 9, 2016. It could have been something I picked up before the flu shot but it is very unusual for me to get sick. I have had egg sized swelling in the past with flu shots but never any swelling as large as this. I have never become ill after receiving a flu shot. I have gotten them every year (27) since I have been employed here. I have gotten the over 65 shot for the past four years without reaction. That's my story.
post xanthem rash on 6/30/05 appeared all over trunk, legs and groin-scattered pink papules without excoreation, on trunk, groin and limbs and cheeks; some very fine. no itching noted.
This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient presented to ED after 2 days of rash with no relief of symptoms from Benadryl.  Received full treatment for anaphylaxis including: Epi-Pen, Solumedrol, Benadryl, Pepcid.
This spontaneous report refers to a 27 years old female patient. The patient was vaccinated with GARDASIL (lot# was unknown) on 21-MAR-2012 at the age of 27. The outcome was unknown. Additional information has been requested
Case number PHEH2014US021632, is an initial spontaneous report received from a consumer (patient's husband) on 24 Oct 2014. This report refers to a 52 years old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of seasonal influenza vaccine (unknown brand name, batch number: not reported) on unspecified dates from four years and experienced discomfort after first flu shot (see related case number: PHEH2014US022185). She was vaccinated with FLUCELVAX (batch number: 140233) at a dose of 0.5 ml in the deltoid on 01 Oct 2014. She felt two things seemed different from previous vaccinations including the location of the injection seemed higher on the arm and she felt different during vaccination which was further described as creaky hinge and similar to when receiving epidural. It was reported that, 2 nights after vaccination her shoulder was painful when she tried to lie on that shoulder. After three weeks it was ok to lie on that shoulder but still had restricted movement. The arm was not sore to touch but movements that require raising the arm above the shoulder or head is painful in that shoulder. She was treated with ibuprofen which was helpful. The final outcome of the events was not reported. The seriousness and causality of the events were not reported.
Discharge Provider: Primary Care Provider :  6/28/2022 - 7/11/2022 (13 days) Hospitals -   PRESENTING PROBLEM: Acute metabolic encephalopathy   HOSPITAL COURSE: Patient is an 89 year old with PMHx of CAD, CLL, CAD, Parkinson's who presented to the hospital with acute metabolic encephalopathy. Patient recently admitted for a similar event from 6/3-6/15, found to have enterococcus  UTI. Extensive work up at that time including MRI, EEG, and LP were unremarkable. Patient was able to have improvement on its own as the UTI was treated. Patient was re-admitted, Urine + for UTI, growing enterococcus again. Patient also + for COVID-19, family members were sick prior to admission. Patient was very confused again, not oriented to anything. He had an EEG done which was negative. Neurology consulted, and recommended treating underlying infections. Patient required restraints early in his hospital stay. Slowly his mental status improved. He was evaluated by SLP and PT/OT who recommended subacute rehab. Patient was switched to amoxicillin to completed a 14 day course of treatment. Patient was recommended to follow up with Urology as an outpatient to evaluate his recurrent UTIs. Patient had to stay in COVID isolation until he was cleared for subacute rehab. Patient was ultimately discharged to Assisted living with home therapy.
Hurt for 2 days; Ache; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt for 2 days), PAIN (Ache) and FATIGUE (Felt tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN (Hurt for 2 days), PAIN (Ache) and FATIGUE (Felt tired). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Ache, at an unspecified dose and frequency. At the time of the report, PAIN (Hurt for 2 days), PAIN (Ache) and FATIGUE (Felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment medication aspirin was taken for all events.   No concomitant medication was provided.
Severe diarrhea and during the morning of 11/26/2009 could not urinate. I started taking Avodart on 11/25/2009 9:30PM
I began feeling deeply fatigued and achy about six hours after the vaccination and went to bed.  The aches and fatigue continued the next day and evening and, additionally, I had a swelling in my left wrist of the arm that I had the shot in.  That swelling was painful; it  was about an inch across and looked like it contained fluid.  All those symptoms continued for two more days and then the swelling began to subside and is now gone..  Today, the morning of the fifth day after the vaccination, I awoke at 3 a.m. with severe body aches, took two Tylenol and eventually was able to sleep again.  I am feeling better but very, very tired and have some bodyaches and headache but not as severe.
Day 1 after shot , left arm was swollen and a little red at shot site  and had a mild fever, of 98.5  normal temp for me is around 97.2. Day 2 the red area around the shot site has grown about 2" X 3" and the site itches, and swollen where the red mark is, and hurts to the touch.
HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, and fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and muscle pain was not reported. This report was non-serious.
I started getting symptoms of headache, low grade fever that continued for 4 days. I had a mild cough as well. I took an at home COVID-19 test that was positive. I did a telehealth visit and got a prescription for Paxlovid. I do feel like the Paxlovid did help but my symptoms were mild. My symptoms lasted for 5 days.
Patient got a fever that night of 104.0 with chills.....fever and chills lasted 2 days. He did not seek medical attention.
Same as first dose, triggered asthma, scratchy throat, no rash, no hives, cleared with 25 mg PO benadryl, her own albuterol inhaler, PO H20, relief, back to normal  25 mg PO benadryl, pepcid PO, 10 mg zyrtec to take home
Pt received varicella vaccine at 15 month old office visit as part of routine immunization. Pt started with a few vesicles, 10 days prior to admission. Was treated with calamine lotion and Aveeno baths at home, but vesicles worsened. Lesions in oral cavity and throat. Pt brought th ER and admitted PICU for airway management and treatment of varicella, sepsis and pneumonitis. Treated with diphenhydramine, Acyclovir, clindamycin, ceftriaxone and acetaminophen. Discovered after admission was an underlying T-cell abnormality that would have made live vaccines contraindicated.
Injection not given in deltoid but rather into shoulder.  Day after injection I had anterior shoulder pain and could not lift my arm.  It progressively got worse.  Went to all around the shoulder area and extreme/piercing when moving arm and shoulder.  Also clicking on movement.   It has been over 5 months, and I am still dealing with this.  Saw Dr. (family doctor) in March.  Xray done and referred to ortho doc at Ortho clinic (Dr.).  Dr.  prescribed an anti-inflammatory med.  Dr. stated because the pain was from a shot and not injury, this med might work.  He additionally suggested steroid injections if it did not work.  Also suggested physical therapy.  I chose home physical therapy to no avail.  It is now June 29th and I am still having difficulty driving and difficulty performing other day to day activities.
Fever 103.1, chills,  muscle pain, light headed, headache, ringing in ears started at 4pm that same day,  when to ER at hospital and was released in 3 hours with a temp of 99. The fever and other systems lasted the next day. That night I had perfuse night sweats. Wednesday,  still tired no fever, heavy chest feeling. ringing in ears.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant therapies were not provided. On 26-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # as reported M001200, expiration date 28-AUG-2016, dose 2, 0.5 ml, subcutaneous). No adverse event was reported and no product quality complice (PQC) was involved. Additional information has been requested.
No AE; temperature excursion/vaccines were administered to patients; This spontaneous report was received from a certified medical assistant and a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-NOV-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe, dose: 0.5 milliliter, lot # 1637642, expiry date: 28-MAY-2022 (route of administration was not provided) for prophylaxis. Administered dose of vaccine experienced an unknown temperature excursion. The medical assistant stated that there had been multiple temperature excursions recently. The previous excursions were related. Data logger was involved. No adverse events were reported. It was also stated, that remaining vaccines were ok to use because they were still stored within recommended temperature guidelines. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I was supposed to start my period 3 days after receiving the vaccine and have yet to have a period since.
per ER 1 1/2 hrs p/vax,, diaphoresis, lightheadedness; per pt 15-20 minutes p/vax felt hot, pulse 140, BP 200/120;
Mom contacted HD staff on 8/15/01 at 16:45, stating that the child was nauseated and vomiting, fretful and crying and with a temperature of 101F-102F since morning. Denies any edema or redness at injection site. Phone call on 8/17/01 to mom reveals that child is having no problems.
Low grade fever 100.6 Chills Body aches Fatigue Minor diarrhea Less than 24 hours