chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sx started 9-8-09, 9-9-09 including urinary frequency, low abdominal pain, Fever, nausea, wt. loss, diarrhea, right posterior tibial neuropathy. Pt under the care of neurologist at this time.  VAERS report received 10/5/09 and Medical records from Neurologist received 10/9/2009.  Initial Sx: nausea, diarrhea, urinary frequency, low abdominal pain, fever, wt loss and numbness dorsum lt foot. Initially seen per Neurologist 8/21/09 for c/o's numbness lt foot. EMG and NCV studies noted severe lt common peroneal neuropathy, with S1 neuropathy ? etiology. Patient returned to Neurologist on 10/5/2009 with progressive sx of numbness, now in bilateral LE's. A repeat EMG and NCV study noted the existing LCP neuropathy but now with a rt tibial neuropathy. Conclusion: Bilateral lower peripheral neuropathy, neuroallergic reaction to vaccine, however MD could not r/o CIDP. No Tx ordered per MD at this time.  10/13/2009 received hospital records for stay 9/25-9/27/2009. Patient presented with 1 week hx of frequent urination, watery diarrhea and dehydration. stool studies negative, TX: ABX and rehydration. DC DX Watery diarrhea with dehydration and nausea, improved,  Bladder irritability with frequent urination.
Irritability and Fever, treated with Tylenol.  Irritability and pain at injection site has continued. Overnight it developed into gas pain. We are treating with Tylenol and mylecon drops.  Fever of 100.5 is still present the next day.
Ringing ear (Tinnitus). I first notice this a few weeks after the 2nd dose. Since then it became more intense with days. Now it is a constant annoying symptom 24x7, day and night.
This is a serious observational study case initially received from other health professional on 17-Jan-2019, concerning a 29-year-old adult female pregnant subject (center ID: 002) of body weight: 152.8 lbs, height: 65 inches and body mass index (BMI): 25.4, enrolled in V130_11OB, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject had 3 previous pregnancies with two spontaneous abortions and one full term live birth. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. After first pregnancy, the subject had post-partum depression for two months (on an unspecified date) and the current condition included migraines (since an unspecified date). The subject's last menstrual period (LMP) date was 21-Aug-2018. The type of pregnancy was singleton. The subject's concomitant medication included Prenatal vitamins [minerals nos; vitamins nos] for pregnancy. On 20-Oct-2018, the cystic fibrosis mutation analysis and the blood work (PNBW) were performed and on an unspecified date, first trimester screening was performed, the results showed no congenital malformation. On 06-Nov-2018, at gestation age of 11 weeks (first trimester), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF41708, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded to vaccine exposure during pregnancy) for an unknown indication. On 07-Jan-2019, 2 months and 1 day after vaccination, the anatomic scan was performed, which showed hydronephrosis of right fetal kidney (abnormal). At the time of this report, the outcome of the event (prenatal screening test abnormal) was unknown. The estimated delivery date (EDD) was reported as 02-Jun-2019.; Reporter's Comments: A 29-year-old pregnant patient subject was administered Flu Vaccine Egg Split QIV CSL at gestation age of 11 weeks (first trimester) as part of observational safety study (coded to Exposure during pregnancy). Two months after vaccination the anatomic scan performed showed hydronephrosis of right fetal kidney. Despite plausible temporal relationship, there is no evidence for a biological mechanism that could cause the event and therefore the event of hydronephrosis of right fetal kidney was considered not related to the vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine.The company assessed the event (prenatal screening test abnormal) as serious (medically significant).
AREA OF VACCINATION STARTED TO HURT THAT SAME DAY AND CONTINUED TO WORSEN FOR TWO WEEKS. NODULE THAT IS WARM TO TOUCH DEVELOPED FURTHER DOWN ON FOREARM AT SOME POINT. REPORTED TO PHARMACY 6/14 BUT COULD NOT SEE DOCTOR UNTIL 6/18. TRIED ICY HOT, ASPERCREME, BENADRYL, TYLENOL, ICE WITH NO RELIEF. DURING CALL PHARMACIST SUGGESTED SWITCHING FROM TYLENOL TO IBUPROFEN. IBUPROFEN WAS REPORTED TO BRING SOME BUT NOT COMPLETE PAIN RELIEF. DOCTOR STOPPED IBUPROFEN 6/18 AND PRESCRIBED ORAL PREDNISONE AND HEAT THERAPY.
BLACKED OUT; HIT HER HEAD; BLEEDING NOSE; Concussion; SWEATING ALL OVER BODY; DISORIENTATION; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced headache, nausea, sweating, disorientation and fever. She had a black out and hit her head, woke up from the floor and was still feverish and she noticed blood in her nose. She then called her mom to help her because the headache did not go away. 2 days later she called health department and they directed her to emergency room. Computerized tomography scan and a dye scan was done and it was found out that she had a concussion. She hit her head in 2 places. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, sweating all over body, fever, disorientation, blacked out, bleeding nose, concussion and hit her head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210441012 - Blacked out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
This spontaneous report as received from a consumer, as part of a marketing research program, refers to a 14 year old female patient. In 2011, the patient was vaccinated with a dose of GARDASIL. (dose and lot# not reported). In 2011, the patient experienced "distorted skin" reaction at injection sites. The outcome of the event was reported as probably resolved before the third shot. The reporter considered the event to be related to GARDASIL. This is one of several reports received from the same source. Additional information is not expected.
Due to Human error - HIB was accidently given to pt. instead of MENACTRA that was ordered.
Pain at injection site; Chills; Headache; Nausea; Loose stools; Muscle pain and aches; Feeling unwell; Rigors; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 02Apr2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included LVH (left ventricular hypertrophy) and COVID-19 on unknown date. Concomitant medications included acebutolol hydrochloride (SECTRAL) 400mg twice a day and ranolazine (RANEXA); both from unknown dates for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 03:00, the patient experienced pain at injection site, chills, rigors, headache, nausea, loose stools, muscle pain and aches and felt unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of pain at injection site, chills, rigors, headache, nausea, loose stools, muscle pain and aches and felt unwell and included treatment with tylenol (MANUFACTURER UNKNOWN), ZOFRAN and ibuprofen (MANUFACTURER UNKNOWN). The clinical outcome of the events pain at injection site, chills, rigors, headache, nausea, loose stools, muscle pain and aches and felt unwell was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
The patient was diagnosed with cancer after the time of the vaccine; Not receive the second dose of the vaccine and is not outside of the allowed time window; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEOPLASM MALIGNANT (The patient was diagnosed with cancer after the time of the vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (The patient was diagnosed with cancer after the time of the vaccine) (seriousness criterion medically significant) and INCOMPLETE COURSE OF VACCINATION (Not receive the second dose of the vaccine and is not outside of the allowed time window). At the time of the report, NEOPLASM MALIGNANT (The patient was diagnosed with cancer after the time of the vaccine) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Not receive the second dose of the vaccine and is not outside of the allowed time window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included undergone two surgeries to combat that condition. Company comment:Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
arm is very swollen; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is very swollen) and PAIN IN EXTREMITY (arm is sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is very swollen) and PAIN IN EXTREMITY (arm is sore). At the time of the report, PERIPHERAL SWELLING (arm is very swollen) and PAIN IN EXTREMITY (arm is sore) outcome was unknown.            Height was reported as 5.5. No relevant concomitant medications were reported. Patient received her second booster dose. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a 70 year old female who on 06-MAR-2007 was vaccinated with Pneumovax 23 (lot # 655291/0985F) 0.5 ml IM in left deltoid in the morning. Concomitant medication included lisinopril (MSD), ADVAIR, hydrochlorothiazide (MSD). On 06-MAR-2007, later that day, the lower part of patient's left arm below the deltoid became red. "It looks like someone grabbed her arm". The area was warm to touch and the patient had some discomfort. Medical attention was sought. At the time of reporting, the patient was recovering. The office requested a lot check be performed. No further information was available at the time of reporting. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government agency and was released. Additional information was released from the registered nurse. On 06-MAR-2007, the patient experienced multiple areas on her left arm which were red, sore, and warm. The patient was treated with ZYRTEC 10 mg and KEFLEX 500 mg. At the time of reporting, the patient had recovered. No additional information is expected.
Undiluted vaccine was administered to patient.  PCP notified. Father notified and instructed to monitor patient for adverse reaction.
Low-grade fever (99.2); mild body aches, dull headache, lethargy. Responds to Tylenol and rest. At ~19 hours post-onset, symptoms continue
Started to feel facial and arm tingling about 25 min after received JJ vaccine.  Given 50mg Benadryl IM
Around 6:30 pmI began feeling chills and incredibly tired.  I became sore all over and began shaking uncontrollably because of the chills.  I went to sleep around 7pm and woke up 20 minutes laterwith the worst fever I ever had.  I was extremely hot but when I lifted the covers I would immediately get cold.  I got out of bed around 3am because I was very thirsty and completly stuffed up in my head and sinuses.  I used vicks sinex and drank water and tea.  I was very cold when i got out of bed.  I went back to bed and woke up every 30 mins or so very hot and chilly when I lifted the covers.  I finally got out of bed at 6am.  At that point I had sweated through two shirts, my sheets and comforter.  When i got out of bed I was no longer chilly.  I had a mild headache, sinus pressure and soreness throughout my neck and shoulders.  Throughout the day (April 21, 2021) I would get chills and then get hot.  I continued to havce sinus pressure and a mild headache.  I went to bed around 8:30pm and woke up at 3:00am.  when I woke up I had sweated through half my shirt.  At the time of writing (April 22, 2021 @ 6:08am) I feel slight sinus pressure, no headache and get chills and hot from time to time.
On 11/24/2022 I was exposed to a four and a two year old that had had an illness and a positive test for RSV and COVID-19 on 11/21/2022 then on  11/27/2022 at 11PM I had sinus drainage and coughing with  no fever but worse ant night  but enough to deter from regular activities I had a flu shot on 11/30/2022 sinus drainage continued with night time coughing symptoms lessen over the next two week. I had  routine apt schedule on 12/16/2022 and was prescribed Prednisone  Dr reported that may patients had reported the same symptoms.   She and her colleagues were treating inflammation of the upper respiratory system. Symptoms resolved with full recovery no complications.
Current COVID-19 infection, and ESRD on Tuesday/Thursday/Saturday dialysis who presents to the emergency department and due to inability to get transportation to her dialysis center. Patient is not sure why she is here in the emergency department other than "they told me I have COVID and can't get dialysis.". She endorses dizziness when upright, coughing, and sore throat, but denies headache, chest pain, or abdominal pain. When I called her skilled nursing facility, they stated that they called the ambulance to bring her to the emergency department because the normal transportation service she uses to go to dialysis refuses to transport her because she is COVID positive.
Varicella vaccine break through. Diagnosed with varicella on 5-29-09
painful side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (painful side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (painful side effects). At the time of the report, VACCINATION SITE PAIN (painful side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
I am in excruciating pain in my entire arm. The pain spreads into my collarbone and into my neck and shoulder area. It goes all the way down to my thumb. I take Tylenol and flexiril. Have been to the doctors multiple times with an ultrasound appointment this upcoming Tuesday. This is pure misery.  I shouldn?t be taking medicine for this five months after my last shot.
generalized hives over the trunk,legs and arms. Anxious with rapid breathing. Nausea. Patient did not seek care
Whole body stiffening of upper and lower extremities for 10-15 seconds. Short in duration and became more frequent. Patient received antiepileptic medications for thought of seizure activity.
ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-NOV-2021, the patient experienced administered 2.5ml of the vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220129, 20211220619, 20211220155, 20211220145, 20211220250, 20211220262, 20211220916, 20211165041, 20211200723, 20211200752, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202250, 20211202371, 20211165041, 20211202199, 20211202193, 20211202161, 20211201963, 20211201450, 20211201443, 20211201392, 20211201351, 20211201304, 20211201286, 20211201179, 20211201168, 20211200994, 20211201082, 20211200723, 20211200717, 20211219681, 20211200675, 20211220527, 20211220697 and 20211220928.
Moderna COVID-19 Vaccine EUA  Exactly, to the hour, one week after vaccination, site became very itchy, red, hard and warm.
Back pain, joint pain, fever, cough, wheezing. NSAIDS and Theraflu.
Tinnitus in both ears.  Started a few days after 1st vaccine. Received 2nd vaccine on 4/29. No change as of 5/10.
Pain in the arm; Motion sickness; Wakes up middle of night and feel nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), MOTION SICKNESS (Motion sickness) and NAUSEA (Wakes up middle of night and feel nausea) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 023M20A) 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 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm), MOTION SICKNESS (Motion sickness) and NAUSEA (Wakes up middle of night and feel nausea). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Nausea, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Nausea, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm), MOTION SICKNESS (Motion sickness) and NAUSEA (Wakes up middle of night and feel nausea) outcome was unknown.            No concomitant medications reported by reporter. Action taken with mRNA-1273 was not applicable. Action taken with mRNA-1273 in response to the events was not Applicable
Child mistakenly received both a MMR-V and a separate Varicella vaccine as vaccinator thought she was administering a MMR. Child monitored for 30 minutes post vaccination and remained asymptomatic.  Parents infrormed of error.
Pt cried from 3 PM on 4/5/01 until 3:05 AM on 4/6/01. Pt developed a fever of 101.4. Tylenol was given. The fever went down to 99.7.
The patient received his 2nd Pfizer COVID vaccine Tuesday 6/15/2021. Friday morning 6/18/2021 he started having tight chest pain 9/10. He came to the hospital and was found to have myocarditis.  He was treated with NSAIDs and colchicine to good effect. His chest pain resolved after a couple days.
BOOSTER ON NOV 10, 2021. FELT FINE UPON LEAVING CLINIC. WITHIN 12 DAYS, I DEVELOPED HUGH NODULES THROUGHOUT MY LYMPATHIC SYSTEM. IN MY NECK, MY HEAD, MY INNER THIGHS, MY ABDOMEN. MY SKIN DEVELOPED A RASH WITHIN 3 HOURS OF LYMPH NODES. RASH ALL OVER MY TORSO,  BACK, SCALP, ARMS, LEGS. VAGINAL AND BUTTOCK.S THE ITCH WAS HORRID AND INTENSE, ALL NIGHT.  I WENT TO 2 DOCTORS.. RECEIVED A SERIES OF PREDISOINE. ONE DAY AFTER PERSCRIPTION ENDED. RASH WAS WORSE THEN EVER. HORRIBLE. WENT TO DERMATOLOTIST. HE LOOKED AT RASH AND SAID IT WAS PSORASIS. ALL OVER. IN THE PAST, IN MY 40'S I HAD VERY MILD PSORASIS ON MY SCALP, NECK AND ELBOWS. NOTHING LIKE THIS EVER. MY WHOLE BODY WAS INFECTED WITH PSORASIS. THE DOCTOR DID NOT WANY ANY MORE PREDISONE. HE GAVE ME A STERIOD CREAM.  AND WANTED ME TO USE THEIR UVB LIGHT.  MY RASH HAS LIGHTENED UP, BUT IT IS STILL HORRIBLE.  MY LEGS, MY BODY LOOK AWFUL. I STARTED LOSING MY HAIR WHEN THE RASH FIRST APPEARED. THAT IS STILL GOING ON.. HORRIBLE HAIR LOSS, LIKE A CHEMO PATIENT. NOTHING LIKE THIS HAS EVER HAPPENED TO ME. MY SKIN STILL BURNS.  THIS VACINNE DID THIS TO ME.  I AM WORKING ON ALL KINDS OF HOMEOPATHIC REMEDIES.   THIS IS AWFUL.  I COULD NOT TAKE MODERNA, DUE TO VANCOMYCIN  REACTION 13 YEARS AGO. JAND J WAS MY ONLY OPTION. CLEARLY I WILL NEVER TAKE THIS AGAIN. PEOPLE NEED TO BE INFORMED OF SKIN REACTIONS.,THIS IS NOT RIGHT.
Several symptoms -  achy, chills, low grade fever - present 2/5/2021 loose bowels, sore arm - present 2/5/2021 and still present 2/6/2021
p/vax pt exp pain in arm & leg; could not get out of bed; had to crawl down the stairs;