chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Gardasil vaccine on 3/20/2007 and 5/18/2007.  Developed seropositive RA by 6/2007.  Requires disease-modifying therapy.  1/29/08 Reviewed reporter's medical records which reveal patient seen 1/8/08 as arthritis second opinion.  Patient had experienced pain in hands & feet, CTS, elbow pain & morning stiffness beginning 6/2007.  Seen by specialist at that time who dx RA & had been on varying doses of steroids since 7/07.  Stated Plaquenil 10/07 but continued to have discomfort, stiffness & swelling of fingers & knees which interfered w/sleep & intermittent fine motor incoordination.  Numbness of lower arms & legs esp at night.  Hands were weak.  Additional meds had been recommended & sought second opinion at that time.  After exam, patient agreed to addition of Methotrexate & folic acid along w/serial labs.  Referred for baseline CXR & hand/foot x-rays to monitor progression. FINAL DX: Rheumatoid arthritis. 2/5/08 Reviewed med records from pcp which reveal patient experienced weakness & pain of right hand on 7/20/07 vs.  Dx w/CTS & tx w/meds & brace.  Returned on 8/22 w/complaints of increasing fatigue, joint pain & stiffness x 3 mos.  Had seen podiatrist & x-ray of feet abnormal.  Labs done & referred to rheumatologist.  10/22 vs for sinusitis & 12/13 for URI.  Referred to 2nd rheumatologist.  Vaccine date/lot # added to VAERS database. FINAL DX: Rheumatoid arthritis. 1/20/2010 Active rheumatoid arthritis.  02/03/2010 Patient has active rheumatoid arthritis (CCP anitbody positive, RF positive).
Severe Itching. Took 25mg of Hydroxyzine. 3 hours later, repeated dose. Itching still did not totally subside. I didn't do anything else. Just waited for itching to subside on it's own about 36 hours later.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # K010323 and expiry date: 10-MAY-2017). No adverse effects were reported. The vaccine was stored as 63F for 156 hours. There was no previous excursion reported and no data logger. No product quality complaint was reported for ROTATEQ. This is one of the two reports from the same reporter. Additional information has been requested.
Arm was sore after first COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore after first COVID vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Non-smoker, Abstains from alcohol and Plaque psoriasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced PAIN IN EXTREMITY (Arm was sore after first COVID vaccine). In 2021, PAIN IN EXTREMITY (Arm was sore after first COVID vaccine) had resolved.    mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. It was unknown if the patient was enrolled in covid-19 vaccine trials. No concomitant product reported by reporter.  The reporter's causality for the event(s) of outbreaks/psoriasis patient experiencing bad breakthrough/broke out with humira 40mg/0.4ml(adalimumab) was a reasonable possibility. No treatment medication reported by reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in. This case was linked to MOD-2021-623323 (Patient Link).
EPILEPSY, UNSPECIFIED 10/27/2022 COVID-19 DISEASE  ACUTE PULMONARY EMBOLISM 10/28/2021 COVID-19 DISEASE  ACUTE DVT OF RIGHT FEMORAL VEIN 10/28/2021 COVID-19 DISEASE
Pt recv vax on 11/5/98; on 11/7/98 pt exp red, swollen area at vax site;tx=Erythromycin, Medrol, cortisone
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment information in response to events was not provided.
It was a typical Tuesday immunization clinic mainly of individuals coming in for their Shingrix vaccine. We had two little girls coming in who were sisters, one was 2 years old and one 5 months old. The oldest girl only needed one vaccine to get up-to-date on her vaccines while the younger girl still receiving infant immunizations so she needed a few more. We were able to provide a combination vaccine (Pentacel) to reduce the amount of pokes she would receive. This was discussed with mom and she okay the combination vaccine of Pentacel to reduce the amount of pokes her baby would receive. There were two nurses in the immunization room prepping the vaccines for administration. Both nurses did look at the vial of Pentacel  looking at the lot number just above the expiration date. The vaccine was administered and then at the end of the day the event was caught while going through paper work. Mom was called right away when the event was found and a voicemail message was left leaving the details. Did also email the lead MICC coordinator for our county for the next step. It is recommended to readminister, but mom does not want to re-administer vaccine.
I got severe mastitis  on both side. I had chills and I was weak and tired. Couldn't get out of bed a few days.  My right leg went numb and went to ER.
Got vaccine while Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M2LA and 011L208A) for COVID-19 vaccination.     The patient's past medical history included Migraine in 2013 and Pregnancy (Live, full-term birth.) on 18-Jan-2019. Concurrent medical conditions included Allergy to antibiotic, Allergy to antibiotic (Cipros) and GERD since 2013. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for GERD, SUMATRIPTAN (IMITREX [SUMATRIPTAN]) and MAGNESIUM for Migraine, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, RIBOFLAVIN for an unknown indication.   On 12-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Jun-2020 and the estimated date of delivery was 04-Apr-2021. On 12-Jan-2021 at 3:30 PM, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 12-Jan-2021 at 3:30 PM, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.         The conception date of patient was on 12-Jul-2020 and date of positive pregnancy test was 22-Jul-2020. The patient has an established prenatal care. Number of fetus was found to be one. Treatment information was not provided.
Patient was vaccinated too early at 20 days instead of 24 days for second Moderna dose. Normally the RN will look up the patient in database prior to vaccination when in the setting to make sure there are no duplicates, however, she does not remember if she did. RN was present at this outreach.
I am four days post vaccination and I am still experiencing discomfort at the injection site, extreme fatigue, and difficulties with mental focus
Pt reported via email - on 28 Jan "I had the shot at 9 AM and at 4 PM I had cold chills and slight shakiness. I had to lie down. By morning (29 Jan) the arm was swollen and hot to the touch. I put ice on it. By noon I had a red mark going down the inside of the arm and across to the elbow where the swelling was. Late afternoon it had disappeared. It is much better today (30 Jan). Still slightly swollen but the heat is gone and almost back to normal."
Right arm pain, redness, swelling, itching, and warmth to touch; Headache; Muscle and Joint Pain; Fatigue; fever and chills
On 12/02 I started having heart palpatations I had an EKG done which came back as abnormal then I was referred to Cardiologist. The Cardiologist confirmed abnormal EKS I had a heart monitor and stress test I was diagnosed with PAC.
Dose administered after improper storage & handling will repeat dose per manufacture recommendation  2/15/22 developed soreness at injection site & Temp 99.8 Tx with Tylenol/Motrin
She got the vaccine at 2:00, around 4:00 she started with fatigue with headache, dizziness, somewhat blurry vision (not extreme), chills up her full spine to her head from the bottom.  She also at that time noticed a lump on her right arm and difficulty raising her arm straight out due to severe intensity of pain.   She had difficulty of neurological function and paralysis and reaction of the right leg to just above the knee into her toes.  She had paralysis feeling and also heavy swelling that was noticed by 6:00 that day.  She also noticed that night that no position gave her comfort to be able to sleep, which kept going and she still has the paralysis, numbness, chills, fatigue.  The headaches are getting sharper, more intense in her right temple area which is very sharp, which is not normal for her.   The tumor she had gave her squeezing headache pain across her eyes and the to of her head but not the temples.   The 2nd shot brought about 3 days of wheezing, which she does  not have any lung or heart issues.  She has been having difficulty with just having normal breathing patter as she does not feel it is quite right for getting oxygen as it had been prior.     She went to her PCP last Friday, 4/16/21 who has ordered an MRI.  He has consulted with the neuro-specialist that she had with her tumor.  He will follow through with more blood work more than likely.  He did mention to her about having a COVID test to double check that end of that.  She did not have this done due to the fact that she had the brain tumor surgery and that is how they did that approach.    She was just staring to have resolution of some of her symptoms from the 1st vaccine from the right leg when she got this one.   When she got the 2nd vaccine she had intense swelling in the left leg from the knee down.   There is a definite difference in the size of the legs.   Her PCP said that there is definite damage from his testing at her recent appointment.
This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
The left arm was tight where the lump was; Lump in the left arm where he received the shot; Left arm pain the area where he got the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TIGHTNESS (The left arm was tight where the lump was), VACCINATION SITE MASS (Lump in the left arm where he received the shot) and VACCINATION SITE PAIN (Left arm pain the area where he got the shot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 02-Feb-2021. Concurrent medical conditions included Blood pressure abnormal, High cholesterol and Diabetes. Concomitant products included METFORMIN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (The left arm was tight where the lump was), VACCINATION SITE MASS (Lump in the left arm where he received the shot) and VACCINATION SITE PAIN (Left arm pain the area where he got the shot). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE TIGHTNESS (The left arm was tight where the lump was) outcome was unknown, VACCINATION SITE MASS (Lump in the left arm where he received the shot) had resolved and VACCINATION SITE PAIN (Left arm pain the area where he got the shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
My infant son's scrotum appeared to be quite red.  He had a bath, bottle, and went to bed as usual, but this redness on his scrotum bothered me.  No treatment has been administered.
Left arm cellulitis; Multiple other bumps going down her arm; Itchiness on her left arm close to the vaccination site; One big welt approximately the size of a nickel; A spontaneous report was received from a 44 year-old, female health care professional, who was also the patient, who received Moderna's COVID-19 vaccine and experienced left arm cellulitis, multiple other bumps going down her arm, itchiness on her left arm close to the vaccination site, and one big welt approximately the size of a nickel.   The patient's medical history was not provided. Concomitant product use was not provided.    On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) in their left arm for prophylaxis of COVID-19 infection.   On the morning of 06 Jan 2021, the patient felt itchiness on her left arm close to the vaccination site. The patient had one big welt approximately the size of a nickel, with multiple other bumps going down her arm. The patient took a diphenhydramine hydrochloride, and her symptoms were improving. The bumps going down her arm were resolving, but not fully resolved. Later, the patient noted that she had experienced cellulitis on her left arm starting eight days after vaccination (06 Jan 2021). She received an injection of triamcinolone acetonide on 11 Jan 2021 that helped with the cellulitis's noticeability.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event cellulitis was unknown. The events multiple other bumps going down her arm, itchiness on her left arm close to the vaccination site, and one big welt approximately the size of a nickel, were considered recovering/resolving.; Reporter's Comments: This case concerns a 44- year old, female, healthcare professional.  The patient's medical history was not provided. The patient experienced a serious  event of cellulitis, injection site pruritis, vaccination site inflammation and papules. The event occurred 9 days after first dose of mRNA-1273 (Lot number: 025J20A).  Vaccination site inflammation is listed on the factsheet and is related to mRNA. 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.
Injection site redness and soreness.  Patient is taking diphenhydramine to reduce skin rash.
10/25/02 Date of vaccine: loss of feeling in right arm all the way to right hand; loss of feeling in left hand 2 days later; Increased anxieties. (No treatment by that physician.) Ongoing loss of feeling. The follow up states "my right arm continues to ache and have loss of feeling as well as my left hand and the back of my right leg and the balls of my feet are sensitive and ach. This is not getting any better 1/22/03.
Patient reported feeling shaky and presented with increased HR and BP five minutes after injection. O2 100% RA. Patient provided with snacks and water.  Status monitored during observation of 30 mins.  All symptoms resolved at discharge from vaccine clinic.
Right arm began to turn red and swollen 10/16/2007pm. Advised to go to ER 10/16/2007. Went to ER, given Bactrim. Called 10/17/2007 3:40pm came to clinic, advised again to go the ER for IV antibiotics. Arm more red and swollen with vc sides at sight of injection of right arm.
10cm induration, inflamed & painful rt buttock; Lt side no rxn; Resolved by 10JUN91;
Patient presented to hospital on 03/19/2021 with hypoxia, NSTEMI, and ischemic cardiomyopathy of EF of 15%.  Daughter elected to proceed to inpatient hospice care.  He died on 03/21/2021.
after 2nd dose had fever, chills, rapid heart rate for 2 days ,  on day 4 cough started, SOB, tachycardia  went to Dr Feb 22nd and was taken off work for 3 months due to above s/s. after ~ 5 months+  and multiple tests and seeing multiple specialist, was  finally back to normal
Pt reports the evening following the vaccine she developed chills and moderate to severe abdominal cramping/pain.  Relieved at first with NSAIDS and rest . 3 nights following her vaccine and every night thereafter she c/o severe abd pain and cramping. Prompted her to go to urgent care where they ruled her out for covid and performed an abdominal exam.  She is concerned to the point where she contemplated going to the ED. She has an appt with her pcp on Monday but I referred her to check in with her OB/GYN and to go to the ED if symptoms again become worrisome.
Vaccine was diluted with 0.13 ml of diluent instead of 1.3ml, so the patient got a more concentrated dosage than recommended.  Patient has not reported any side effects at the moment.
chronical urticaria hives on random places on body.  the bumps go down 30 minutes after taking zyrtec. but the bumps may comes back on anywhere on my body the next day on a random spot again.
Sore left arm, severe headaches (3-4 per week), extreme swelling in feet-from first shot to present  - inside mouth left cheek lining disintegrated into a bloody mess after 14 days after 2nd shot
I experienced issues with my bowels (gastrointestinal issues) and had to see my doctor in at the beginning of May for stomach pain and diarrhea. He performed a CT Scan and a Scope which came back normal and recommend that I could do a trial of taking some steroids to see if my symptoms would improve and if the symptoms didn't improved, he would put me on a immune suppressant.
Mild flu-like symptoms. Low-grade fever. Achy. Fatigue. Symptoms lasted less than 12 hours. I felt fine the next day.
This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9, lot # L036301 and expiry date: 20-DEC-2017, lot # M016193 and expiry date: 24-APR-2018. No concomitant medications were reported. The vaccine was exposed to a temperature frame of 34.5 Fahrenheit for 100 minutes. A data logger was involved. There were no previous excursions. No adverse events were reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
headache; stomach ache; chills; body aches; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), MYALGIA (body aches), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), MYALGIA (body aches), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Pale, pronounced tremors and involuntary jerking movements for prolonged period, 103 degree fever,
PATIENT STATES THAT THE DAY AFTER RECEIVING JANSSEN COVID-19VACCINE SHE HAD FLU LIKE SYMPTOMS, RASH, DIFFICULT BREATHING, REDNESS AROUND EYES, HIVES UNDER EYES AND SORE ARM. PATIENT RECEIVED VACCINE 10/19/2021 AND SHE REPORT TO US THESE ADVERSE REACTIONS TODAY, 11/09/2021. PATIENT STATES SHE CURRENTLY HAS  STARTED HAVE A COUGH, HAS SHORTNESS OF BREATH AT TIMES WITH DIFFICULTY BREATHING, INCREASE HEART RATE, SORE ELBOW WITH ALL OTHER SYMPTOMS RESOLVING. PATIENT NOW STATES SHE HAD AN ADVERSE REACTION SIMILAR TO THIS EVENT IN THE PAST TO A FLU VACCINE. PATIENT DID NOT PROVIDE EXACT DATE. PATIENT ANSWERED "NO" TO THE QUESTION ABOUT HAVING ADVERSE REACTS TO VACCINES ON COVID-19 QUESTIONNAIRE AND "NO" TO OUR VERBAL QUESTION ABOUT HAVING ANY REACTIONS TO FLU SHOTS OR VACCINATIONS.  PATIENT STATES SHE HAS A PRIMARY CARE PHYSICIAN BUT HAS NOT CONTACT THE PHYSICIAN ABOUT THESE SYMPTOMS TO DATED. WE TOLD PATIENT SHE SHOULD CALL HER PHYSICIAN NOW AND SEE HER PHYSICIAN.
Tinnitus (03/19/2021 - Current) Onset 1 hour after 1st shot, after 2nd shot on 04/09/2021 it increased severely and it now impacts my quality of life.  Fever (03/20/2021 - 03/24/2021) 102 peaked around noon  Joint Pain (03/20/2021 - 05/01/21) Highest level made mobility & work difficult, was highest following both shots.  Nausea (03/31/2021 - 05/20/2021) Difficulty eating, OTC nausea meds didn't help at all.  Gastrointestinal Distress (04/05/2021 - 06/03/2021)
Pt recv vax on 1/25/99; on 1/26/99 pt exp vax site swelling to below elbow w/ numbness in hand; tx=Benadryl & Medrol
The day after my 3rd COVID vaccine I had pain and swelling in my legs and feet. I went to the emergency room where the doctor admitted me overnight with blood clots in both legs. I am currently taking Eliquis, 5mg, twice daily, to try to dissolve the clots.